Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers - SAD
Study identifier:D1950C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 including an Open Food Effect Panel in Healthy Male and Non-fertile Female Volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1446
Sex
All
Actual Enrollment
110
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Dec 2008
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Apr 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD1446 Oral or placebo Single oral administration of AZD1446 or placebo | Drug: AZD1446 oral, single dose |
| Experimental: AZD1446 Oral, with or without food Single oral administration of AZD1446 with or without food | Drug: AZD1446 oral, single dose |
Contacts
Investigators
Principal Investigator
Didier Meulien
AstraZeneca Södertälje
