Exploratory study to assess the pharmacokinetics of AZD5985
Study identifier:D2300C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Exploratory Phase I, Single centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5985, placebo
Sex
Male
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Nov 2008
Primary Completion Date: 01 Feb 2009
Study Completion Date: 01 Feb 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
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: A AZD5985 | Drug: AZD5985 Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits. |
| Experimental: B placebo | Drug: placebo Oral suspension. |
Contacts
Investigators
Principal Investigator
Eva Pettersson
AstraZeneca R&D, Lund, Sweden
