Double-blind placebo-controlled 2-part study assessing the safety, tolerability and PK of AZD1386 in healthy volunteers
Study identifier:D5090C00021
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1386, Placebo for AZD1386, Naproxen, Placebo for Naproxen
Sex
All
Actual Enrollment
11
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety 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: Part A: A AZD1386 | Drug: AZD1386 Single ascending and multiple (twice daily) oral doses, capsule |
| Experimental: Part A: B Placebo for AZD1386 | Drug: Placebo for AZD1386 Single ascending and multiple (twice daily) oral doses, capsule |
| Experimental: Part B: A Naproxen | Drug: Naproxen Tablet, single oral dose, 500mg |
| Experimental: Part B: B Placebo for Naproxen | Drug: Placebo for Naproxen Tablet, single oral dose |
Contacts
Investigators
Principal Investigator
Richard Leff
AstraZeneca Pharmaceuticals, Wilmington, UK
