Study identifier:D2710C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A randomized, blind, placebo-controlled, single-centre phase I study in healthy volunteers to assess the safety, tolerability and pharmacokinetics of AZD7687 after single ascending oral doses
Healthy
Phase 1
Yes
AZD7687, Placebo
Male
64
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
Location
Location
Overland Park, KS, United States
Arms | Assigned Interventions |
---|---|
Experimental: Active AZD7687 oral suspension | Drug: AZD7687 Single oral dose |
Experimental: Placebo placebo oral suspension | Drug: Placebo Single oral dose |
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