A study to evaluate safety and tolerability after single oral dosing of AZD1656 in Japanese healthy volunteers
Study identifier:D1020C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Oral Doses of AZD1656 in Japanese Healthy Male Volunteers
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1656
Sex
Male
Actual Enrollment
36
Study type
Interventional
Age
20 Years - 40 Years
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Dec 2008
Study Completion Date: 01 Dec 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group) | Drug: AZD1656 Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
