Study identifier:D2060C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A randomised, single-blind, placebo-controlled, single-centre phase I study in healthy Japanese male volunteers to assess the safety, tolerability and pharmacokinetics of AZD4017 after single ascending oral doses
Healthy
Phase 1
Yes
AZD4017, Placebo
Male
56
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Other
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
Location
Location
Fukuoka, Japan
Arms | Assigned Interventions |
---|---|
Experimental: 1 AZD4017 in ascending doses (start dose 2mg) | Drug: AZD4017 ascending single doses (start dose 2 mg), oral suspension |
Placebo Comparator: 2 Placebo | Drug: Placebo placebo |
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