Study identifier:D9441C00003
ClinicalTrials.gov identifier:NCT06948006
EudraCT identifier:N/A
CTIS identifier:N/A
An Open-label, Randomised, 2-arm, 3-period, 6-treatment Single-dose, Crossover Study Comparing the Pharmacokinetics of 2 Different Formulations of AZD4144, and Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
Healthy Participants
Phase 1
Yes
AZD4144, Omeprazole
All
32
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2025 by AstraZeneca
AstraZeneca
PAREXEL
The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.
This is an open-label, randomized, single-dose, crossover Phase I study. The study will comprise: 1. A Screening Period of 28 days. 2. Three Residential Periods 3. A final Follow-up period within 7 to 10 days after the last dose of study drug. There will be a minimum washout period of 7 days between each AZD4144 dose. This study includes the following 2 arms: Arm 1 consists of 3 treatments: 1. Treatment A: AZD4144 dose 1 as tablet (under fasted condition) 2. Treatment B: AZD4144 dose 1 as tablet (under fed condition) 3. Treatment C: AZD4144 dose 1 as an oral solution (under fasted condition) Arm 2 consists of 3 treatments: 1. Treatment D: AZD4144 dose 2 as tablet (under fasted condition) 2. Treatment E: AZD4144 dose 2 as tablet (under fed condition) 3. Treatment F: Omeprazole once daily for 4 days, followed by a single dose of omeprazole along with a single dose of AZD4144 dose 2 as tablet (under fasted condition). The participants will be randomised to one of the following treatment sequences: Arm 1: ABC, BCA or CAB Arm 2: DEF or EDF
Location
Location
Harrow, United Kingdom, HA1 3UJ
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1: AZD4144 Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions. | Drug: AZD4144 Participants will receive AZD4144 orally. |
Experimental: Arm 2: AZD4144 + Omeprazole Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F). | Drug: AZD4144 Participants will receive AZD4144 orally. Drug: Omeprazole Participants will receive omeprazole orally. |
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