Study to investigate single ascending oral doses of AZD5213 in Healthy Male and non fertile Female Subjects
Study identifier:D3030C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)
Medical condition
Tolerability
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5213, Placebo
Sex
All
Actual Enrollment
88
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 May 2010
Primary Completion Date: 01 Dec 2010
Study Completion Date: 01 Dec 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Overland Park, KS, United States
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 dose escalating | Drug: AZD5213 0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses |
| Placebo Comparator: 2 | - |
Contacts
Investigators
Principal Investigator
David Mathews
Quintiles
