This is a study to evaluate the safety, tolerability and pharmacokinetics (PK) of AZD9742 after single IV doses in healthy subjects

Study identifier:D2690C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 after Single Ascending Doses in Healthy Male and Female Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9742, Placebo to match AZD9742

Sex

All

Actual Enrollment

Study type

Interventional

Age

23 Years - 45 Years

Date

Study Start Date: 01 Nov 2009

Primary Completion Date: 01 Mar 2010

Study Completion Date: 01 Mar 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Quintiles, Inc.

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

Arms	Assigned Interventions
Experimental: AZD9742 IV Infusion Active	Drug: AZD9742 Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee
Placebo Comparator: Placebo to AZD9742 IV Infusion Placebo	Drug: Placebo to match AZD9742 Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

Documents available

Cancer Study Locator (US and CA only)
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1286&filename=CSR-D2690C00001.pdf
Download
CSR-D2690C00001.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Locator Service

877-400-4656

astrazeneca@emergingmed.com

Investigators

Principal Investigator

Dr. Ralph A Schutz

Quintiles, Inc