Study identifier:D3550C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, two-part study to investigate the effects of food on the PK, safety and tolerability of a single oral dose of AZD5069 (120 mg) in healthy adult volunteers (Part A) and to compare the PK of AZD5069 in adult and elderly healthy volunteers (Part B)
Chronic Obstructive Pulmonary Disease
Phase 1
Yes
AZD5069
All
24
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Quintiles
AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD). This is not the first 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 in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.
Location
Location
London, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: 1 AZD5069 following a 10-hour fast | Drug: AZD5069 120mg single oral dose |
Experimental: 2 AZD5069 30 minutes after the start of a high fat meal | Drug: AZD5069 120mg single oral dose |
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