Study identifier:D3550C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 after Administration of Multiple Ascending Doses for 8 days in Healthy Male or Female Subjects
Healthy
Phase 1
Yes
AZD5069, Placebo
All
8
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects. AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.
Location
Location
LONDON BRIDGE, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: 1 | Drug: AZD5069 oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7 |
Placebo Comparator: 2 | Drug: Placebo oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7 |
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