Japanese single and multiple ascending dose (JSMAD), safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) study of AZD5069 - JSMAD

Study identifier:D3550C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2009-018185-35

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5069, Placebo

Sex

All

Actual Enrollment

63

Study type

Interventional

Age

20 Years - 65 Years

Date

Study Start Date: 01 May 2010
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria