Study to evaluate safety, tolerability and pharmacokinetics (PK) (including food effect) of oral doses of AZD5847 in healthy volunteers
Study identifier:D3430C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (including food effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing potential
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD5847, Placebo to AZD5847
Sex
All
Actual Enrollment
64
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Dec 2009
Primary Completion Date: -
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Quintiles, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD5847 oral suspension Active | Drug: AZD5847 Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1. Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal |
| Placebo Comparator: Placebo to AZD5847 Placebo | Drug: Placebo to AZD5847 In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1 |
Contacts
Investigators
Principal Investigator
Dr. Patricia A Meier
Quintiles, Inc
