A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (what does the body does to the drug) of Rosuvastatin to Measure the Relative Bioavailability (the extent to which a drug or other substance becomes available to the body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet

Study identifier:D7550C00002

ClinicalTrials.gov identifier:NCT02963116

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tablet Formulation and the Food Effect of AZD5718.

Medical condition

High risk coronary artery disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5718 IR tablet, AZD5718 oral suspension, Rosuvastatin tablet

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 20 Dec 2016

Primary Completion Date: 01 Mar 2017

Study Completion Date: 01 Mar 2017

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Feb 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

For inclusion in the study, subjects should fulfill the following criteria:
1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Healthy male and/or female subjects (of non childbearing potential) aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
3. Females must have a negative pregnancy test at the Screening Visit and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria
3.1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral ophorectomy or bilateral salpingectomy but excluding bilateral tubal ligation.
4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
5. Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study.

Exclusion Criteria

Subjects will not enter the study if any of the following exclusion criteria are fulfilled:
1. History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
2. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or admission to the study unit as judged by the PI including: − Aminotransferase (ALT) > upper limit of normal (ULN); − Aspartate aminotransferase (AST) >
ULN; − Total bilirubin (TBL) > ULN; and − Gamma glutamyl transpeptidase (GGT) > ULN.
5. Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the study unit, as judged by the PI defined as any of the following: − Systolic BP (SBP) < 90 mmHg or ≥ 140 mmHg; − Diastolic BP (DBP) < 50 mmHg or ≥ 90 mmHg; and − Pulse < 45 or > 85 beats per minute (bpm).
6. Any clinically significant abnormalities (at the Screening Visit and admission) in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
8. Subjects with myopathy.
9. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
10. Plasma donation within 1 month of the Screening Visit or any blood donation/loss more than
500 mL during the 3 months prior to the Screening Visit.
11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718 and/or rosuvastatin.
12. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
13. Positive screen for drugs of abuse or cotinine at the Screening Visit or on each admission to the study center or positive screen for alcohol on each admission to the study center.
14. Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.
15. Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
16. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Note: Hormonal replacement therapy is not allowed for females.
17. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
18. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives. 19. Subjects who have previously received AZD5718.
20. Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
21. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order In addition, the following is considered a criterion for the exclusion from the optional genetic component of the study:
22. Previous bone marrow transplant.
23. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.

Location

Research Site

London, United Kingdom, HA1 3UJ

Arms	Assigned Interventions
Experimental: Treatment A 10 mg rosuvastatin tablet alone (fasting state)	-
Experimental: Treatment B 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)	-
Experimental: Treatment C 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)	-
Experimental: Treatment D 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)	-
Experimental: Treatment E 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)	-

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at PAREXEL Early Phase Clinical Unit London, Level 7, Northwick Park Hospital in London. Healthy male participants were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All randomized participants underwent a screening period of maximum 28 days. As part of screening, Inclusion/exclusion criteria, demographic data, medical history, urinary drug/alcohol/cotinine screen, serology were assessed after receiving a signed Informed consent from the participants.

Reporting Groups

	Description
Randomized participants	Randomized set consisted of all participants randomized to 1 of 2 treatment sequences (ABCDE/BACDE) and who received 5 treatments (with 7 days washout period between each): A: rosuvastatin tablet; B: rosuvastatin tablet + AZD5718 immediate release (IR) tablet; C: AZD5718 IR tablet; D: AZD5718 oral suspension; E: AZD5718 IR tablet. Treatments A, B, C and D were administered in the fasted state and treatment E was in the fed state.

Description

Randomized participants

Randomized set consisted of all participants randomized to 1 of 2 treatment sequences (ABCDE/BACDE) and who received 5 treatments (with 7 days washout period between each): A: rosuvastatin tablet; B: rosuvastatin tablet + AZD5718 immediate release (IR) tablet; C: AZD5718 IR tablet; D: AZD5718 oral suspension; E: AZD5718 IR tablet. Treatments A, B, C and D were administered in the fasted state and treatment E was in the fed state.

Participant Flow: Overall Study

	Randomized participants
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Randomized participants	Randomized set consisted of all participants randomized to 1 of 2 treatment sequences (ABCDE/BACDE) and who received 5 treatments (with 7 days washout period between each): A: rosuvastatin tablet; B: rosuvastatin tablet + AZD5718 IR tablet; C: AZD5718 IR tablet; D: AZD5718 oral suspension; E: AZD5718 IR tablet. Treatments A, B, C and D were administered in the fasted state and treatment E was in the fed state.

Description

Randomized participants

Randomized set consisted of all participants randomized to 1 of 2 treatment sequences (ABCDE/BACDE) and who received 5 treatments (with 7 days washout period between each): A: rosuvastatin tablet; B: rosuvastatin tablet + AZD5718 IR tablet; C: AZD5718 IR tablet; D: AZD5718 oral suspension; E: AZD5718 IR tablet. Treatments A, B, C and D were administered in the fasted state and treatment E was in the fed state.

Baseline Measures

	Randomized participants
Number of Participants [units: Participants]	12
Age Continuous [units: Years] Mean ± Standard Deviation	34.7 ± 8.0
Sex: Female, Male [units: Participants]
Female	0
Male	12
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	10
More than one race	0
Unknown or Not Reported	0
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0
Not Hispanic or Latino	12
Unknown or Not Reported	0

Outcome Measures

1. Primary Outcome Measure: Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B. [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Primary
Measure Name	Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B.
Measure Description	To evaluate AUC of rosuvastatin when administered alone and in combination with AZD5718 in treatments A and B
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least treatments from the first 2 periods (rosuvastatin alone and rosuvastatin + AZD5718 IR tablet) and for whom at least 1 ofthe primary pharmacokinetic (PK) parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of the PK data.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state

Measured Values

	Treatment A	Treatment B
Number of Participants Analyzed [units:participants]	12	12
Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B. [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)	41.00 (50.3%)	50.47 (54.9%)

Statistical Analysis 1 for Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment A
Other^[5]	46.87
95% Confidence Interval	( 31.68 to 69.36 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment B
Other^[5]	46.79
95% Confidence Interval	( 31.71 to 69.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under plasma concentration-time curve from time zero to infinity (AUC) of rosuvastatin following treatments A and B.

Groups^[1]	All groups
Other^[5]	99.82
90% Confidence Interval	( 85.76 to 116.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

2. Primary Outcome Measure: Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B. [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Primary
Measure Name	Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B.
Measure Description	To evaluate AUC(0-last) of rosuvastatin when administered alone and in combination with AZD5718 in treatments A and B
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least treatments from the first 2 periods (rosuvastatin alone and rosuvastatin + AZD5718 IR tablet) and for whom at least 1 ofthe primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of the PK data.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state

Measured Values

	Treatment A	Treatment B
Number of Participants Analyzed [units:participants]	12	12
Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B. [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)	45.26 (67.6%)	43.46 (54.7%)

Statistical Analysis 1 for Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment A
Other^[5]	45.26
95% Confidence Interval	( 32.02 to 63.98 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment B
Other^[5]	43.46
95% Confidence Interval	( 30.74 to 61.43 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Area under plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-last]) of rosuvastatin following treatments A and B.

Groups^[1]	All groups
Other^[5]	96.01
90% Confidence Interval	( 86.73 to 106.29 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Primary Outcome Measure: Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B. [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Primary
Measure Name	Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B.
Measure Description	To evaluate Cmax of rosuvastatin when administered alone and in combination with AZD5718 in treatments A and B
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least treatments from the first 2 periods (rosuvastatin alone and rosuvastatin + AZD5718 IR tablet) and for whom at least 1 ofthe primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of the PK data.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state

Measured Values

	Treatment A	Treatment B
Number of Participants Analyzed [units:participants]	12	12
Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B. [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)	4.590 (72.1%)	5.743 (62.9%)

Statistical Analysis 1 for Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment A
Other^[5]	4.590
95% Confidence Interval	( 3.218 to 6.548 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B.

Groups^[1]	Treatment B
Other^[5]	5.743
95% Confidence Interval	( 4.026 to 8.193 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Observed maximum plasma concentration (Cmax) of rosuvastatin following treatments A and B.

Groups^[1]	All groups
Other^[5]	125.11
90% Confidence Interval	( 107.15 to 146.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

4. Secondary Outcome Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of rosuvastatin following treatments A and B. [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of rosuvastatin following treatments A and B.
Measure Description	To evaluate t1/2 of rosuvastatin when administered alone (Treatment A) and in combination with AZD5718 (Treatment B)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least treatments from the first 2 periods (rosuvastatin alone and rosuvastatin + AZD5718 IR tablet) and for whom at least 1 ofthe primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of the PK data.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state

Measured Values

	Treatment A	Treatment B
Number of Participants Analyzed [units:participants]	12	12
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of rosuvastatin following treatments A and B. [units: Hour] Mean (Standard Deviation)	15.97 (6.089)	16.37 (5.719)

No statistical analysis provided for Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of rosuvastatin following treatments A and B.

5. Secondary Outcome Measure: Time to reach maximum observed plasma concentration (tmax) of rosuvastatin following treatments A and B. [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Time to reach maximum observed plasma concentration (tmax) of rosuvastatin following treatments A and B.
Measure Description	To evaluate t1/2 of rosuvastatin when administered alone (Treatment A) and in combination with AZD5718 (Treatment B)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least treatments from the first 2 periods (rosuvastatin alone and rosuvastatin + AZD5718 IR tablet) and for whom at least 1 ofthe primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of the PK data.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state

Measured Values

	Treatment A	Treatment B
Number of Participants Analyzed [units:participants]	12	12
Time to reach maximum observed plasma concentration (tmax) of rosuvastatin following treatments A and B. [units: Hour] Median (Full Range)	5.00 (0.50 to 6.00)	2.00 (2.00 to 5.00)

No statistical analysis provided for Time to reach maximum observed plasma concentration (tmax) of rosuvastatin following treatments A and B.

6. Secondary Outcome Measure: Area under plasma concentration-time curve from time zero to infinity (AUC) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Area under plasma concentration-time curve from time zero to infinity (AUC) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate AUC of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Area under plasma concentration-time curve from time zero to infinity (AUC) of AZD5718 following treatments B, C, D and E [units: h*nmol/L] Geometric Mean (Geometric Coefficient of Variation)	3591 (22.6%)	3559 (20.1%)	4892 (22.2%)	3330 (20.5%)

No statistical analysis provided for Area under plasma concentration-time curve from time zero to infinity (AUC) of AZD5718 following treatments B, C, D and E

7. Secondary Outcome Measure: Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC[0-last]) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC[0-last]) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate AUC(0-last) of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC[0-last]) of AZD5718 following treatments B, C, D and E [units: h*nmol/L] Geometric Mean (Geometric Coefficient of Variation)	3459 (24.0%)	3432 (19.7%)	4649 (21.8%)	3207 (19.9%)

No statistical analysis provided for Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUC[0-last]) of AZD5718 following treatments B, C, D and E

8. Secondary Outcome Measure: Observed maximum plasma concentration (Cmax) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Observed maximum plasma concentration (Cmax) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate Cmax of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Observed maximum plasma concentration (Cmax) of AZD5718 following treatments B, C, D and E [units: nmol/L] Geometric Mean (Geometric Coefficient of Variation)	544.9 (30.4%)	530.2 (41.1%)	1170 (37.3%)	409.2 (29.0%)

No statistical analysis provided for Observed maximum plasma concentration (Cmax) of AZD5718 following treatments B, C, D and E

9. Secondary Outcome Measure: Time to reach maximum observed plasma concentration (tmax) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Time to reach maximum observed plasma concentration (tmax) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate tmax of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Time to reach maximum observed plasma concentration (tmax) of AZD5718 following treatments B, C, D and E [units: Hour] Median (Full Range)	2.01 (2.00 to 5.05)	3.00 (2.00 to 5.00)	1.00 (0.98 to 2.02)	4.00 (3.00 to 5.98)

No statistical analysis provided for Time to reach maximum observed plasma concentration (tmax) of AZD5718 following treatments B, C, D and E

10. Secondary Outcome Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate t1/2 of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of AZD5718 following treatments B, C, D and E [units: Hour] Mean (Standard Deviation)	14.96 (7.237)	13.95 (5.350)	13.55 (3.360)	13.71 (2.455)

No statistical analysis provided for Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2) of AZD5718 following treatments B, C, D and E

11. Secondary Outcome Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate CL/F of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718 following treatments B, C, D and E [units: Litre/Hour] Mean (Standard Deviation)	127.6 (28.12)	128.1 (25.63)	93.55 (20.40)	136.9 (25.53)

No statistical analysis provided for Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718 following treatments B, C, D and E

12. Secondary Outcome Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718 following treatments B, C, D and E [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718 following treatments B, C, D and E
Measure Description	To evaluate Vz/F of AZD5718 (IR tablet/oral suspension) when administered alone (Treatment B) and in combination with rosuvastatin (Treatments C, D and E)
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718 following treatments B, C, D and E [units: Litre/Hour] Mean (Standard Deviation)	2857 (2038)	2611 (1247)	1794 (483.2)	2656 (460.9)

No statistical analysis provided for Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718 following treatments B, C, D and E

13. Secondary Outcome Measure: Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D
Measure Description	To evaluate the relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension in fasted state in treatments C and D, by assessment of AUC, AUC(0-last) and Cmax
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state

Measured Values

	Treatment C	Treatment D
Number of Participants Analyzed [units:participants]	12	12
Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D [units: hng/mL; hng/mL and ng/mL] Geometric Least Squares Mean (95% Confidence Interval)
AUC (h*nmol/L)	3498 (3009 to 4067)	4892 (4208 to 5688)
AUC(0-last) (h*nmol/L)	3432 (3011 to 3911)	4649 (4080 to 5299)
Cmax (nmol/L)	530.2 (416.9 to 674.3)	1170 (920.4 to 1488)

Statistical Analysis 1 for Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D

Groups^[1]	All groups
Other^[5]	71.51
90% Confidence Interval	( 63.80 to 80.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	AUC - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D

Groups^[1]	All groups
Other^[5]	73.81
90% Confidence Interval	( 66.21 to 82.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	AUC(0-last) - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Comparison of relative bioavailability of AZD5718 IR tablet versus AZD5718 oral suspension following treatments C and D

Groups^[1]	All groups
Other^[5]	45.30
90% Confidence Interval	( 36.09 to 56.86 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Cmax - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

14. Secondary Outcome Measure: The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions [ Time Frame: Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose ]

Measure Type	Secondary
Measure Name	The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions
Measure Description	To evaluate the PK parameters of AZD5718 IR tablet when administered in fasted (Treatment C) and fed (Treatment E) conditions, by assessment of AUC, AUC(0-last) and Cmax
Time Frame	Days 1 to 3: Pre-dose and 0.5, 1 to 6 hours, 8, 10, 12, 18, 24, 36 and 48 hours post-dose
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least 1 AZD5718 treatment and for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact the analysis of PK data.

Reporting Groups

	Description
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment C	Treatment E
Number of Participants Analyzed [units:participants]	12	12
The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions [units: hng/mL; hng/mL and ng/mL] Geometric Least Squares Mean (95% Confidence Interval)
AUC (h*nmol/L)	3477 (3026 to 3996)	3330 (2920 to 3798)
AUC(0-last) (h*nmol/L)	3432 (3029 to 3888)	3207 (2831 to 3633)
Cmax (nmol/L)	530.2 (426.2 to 659.7)	409.2 (328.9 to 509.2)

Statistical Analysis 1 for The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions

Groups^[1]	All groups
Other^[5]	95.79
90% Confidence Interval	( 86.88 to 105.61 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	AUC - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions

Groups^[1]	All groups
Other^[5]	93.46
90% Confidence Interval	( 84.27 to 103.65 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	AUC(0-last) - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for The PK parameters of AZD5718 IR tablet when administered in fed and fasted conditions

Groups^[1]	All groups
Other^[5]	77.18
90% Confidence Interval	( 62.71 to 94.99 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Cmax - Pairwise comparison
[5]	Other relevant estimation information:
	No text entered.

15. Secondary Outcome Measure: Safety and tolerability of AZD5718 IR tablet and AZD5718 oral suspension by assessment of the number of adverse events (AEs) following administration of single oral dose in Treatments B, C, D and E. [ Time Frame: At screening (Days -28 to -2); Day -1; Days 1 to 3 and follow-up visit (7 to 10 days post final dose) ]

Measure Type	Secondary
Measure Name	Safety and tolerability of AZD5718 IR tablet and AZD5718 oral suspension by assessment of the number of adverse events (AEs) following administration of single oral dose in Treatments B, C, D and E.
Measure Description	Safety and tolerability variables included AEs, vital signs (body temperature, blood pressure and pulse), resting 12-Lead electrocardiogram (ECG), clinical laboratory safety evaluations (haematology, clinical chemistry and urinalysis) and physical examinations. Clinically relevant abnormalities in clinical lab results, vital signs and ECG assessments were reported as AEs
Time Frame	At screening (Days -28 to -2); Day -1; Days 1 to 3 and follow-up visit (7 to 10 days post final dose)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least period 1 treatment (rosuvastatin alone or rosuvastatin + AZD5718 IR tablet) and for whom any safety post-dose data were available.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Measured Values

	Treatment A	Treatment B	Treatment C	Treatment D	Treatment E
Number of Participants Analyzed [units:participants]	12	12	12	12	12
Safety and tolerability of AZD5718 IR tablet and AZD5718 oral suspension by assessment of the number of adverse events (AEs) following administration of single oral dose in Treatments B, C, D and E. [units: Participants]
Any AE	1	1	3	2	1
Any AE with outcome = death	0	0	0	0	0
Any SAE (including events with outcome = death)	0	0	0	0	0
Any AE leading to discontinuation of study drug	0	0	0	0	0

No statistical analysis provided for Safety and tolerability of AZD5718 IR tablet and AZD5718 oral suspension by assessment of the number of adverse events (AEs) following administration of single oral dose in Treatments B, C, D and E.

Serious Adverse Events

Time Frame	At screening (Days -28 to -2); Day -1; Days 1 to 3 and follow-up visit (7 to 10 days post final dose)
Additional Description	AEs that started or worsened at or after the first administration of IMP, until the time of dosing in the next treatment period or until the Follow-up Visit, if the AE occurred in the last treatment period. A subject could have had 1 or more preferred terms reported under a given system organ class.

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Serious Adverse Events

	Treatment A	Treatment B	Treatment C	Treatment D	Treatment E
Total, serious adverse events
# participants affected / at risk	0/12 (0.00%)	0/12 (0.00%)	0/12 (0.00%)	0/12 (0.00%)	0/12 (0.00%)

Other Adverse Events

Time Frame	At screening (Days -28 to -2); Day -1; Days 1 to 3 and follow-up visit (7 to 10 days post final dose)
Additional Description	AEs that started or worsened at or after the first administration of IMP, until the time of dosing in the next treatment period or until the Follow-up Visit, if the AE occurred in the last treatment period. A subject could have had 1 or more preferred terms reported under a given system organ class.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Treatment A	All randomized participants received orally single dose of rosuvastatin 10 mg tablet alone in fasted state
Treatment B	All randomized participants received orally single dose of AZD5718 IR tablet and rosuvastatin 10 mg tablet in fasted state
Treatment C	All randomized participants received orally single dose of AZD5718 IR tablet alone in fasted state
Treatment D	All randomized participants received orally single dose of AZD5718 200 mg (50 mg/mL) oral suspension alone in fasted state
Treatment E	All randomized participants received orally single dose of AZD5718 IR 200 mg tablet alone in fed state

Other Adverse Events

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Total, other (not including serious) adverse events

# participants affected / at risk

1/12 (8.33%)

3/12 (25.00%)

2/12 (16.67%)

1/12 (8.33%)

Nervous system disorders

Headache¹

# participants affected / at risk

1/12 (8.33%)

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Nervous system disorders

Poor quality sleep¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Gastrointestinal disorders

Nausea¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

General disorders

Influenza like illness¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Infections and infestations

Nasopharyngitis¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal pain¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

Vascular disorders

Hot flush¹

# participants affected / at risk

0/12 (0.00%)

1/12 (8.33%)

0/12 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA Version 19.1

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: All clinical study findings and documents will be regarded as confidential. The investigator and members of his/her research team must not disclose such information without prior written approval from the sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Global Clinical Leader
Organization:	AstraZeneca AB
Phone	+46 766 346712
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Dr. Muna Albayaty

PAREXEL Early Phase Clinical Unit London

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Trial Results Summaries