A study to evaluate safety and tolerability after oral dosing of AZD1656 in healthy volunteers
Study identifier:D1020C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction after Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1656
Sex
Male
Actual Enrollment
32
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Sept 2008
Study Completion Date: 01 Sept 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 8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group) | Drug: AZD1656 Dose escalation to achieve maximum tolerated dose |
| Experimental: 2 2 oral doses of AZD1656 given to 2 groups together with food | Drug: AZD1656 Oral single dose |
Contacts
Investigators
Principal Investigator
Klas Malmberg
AstraZeneca R&D Mölndal
