AZD7325 Japan multiple ascending dose (MAD) Study - JMAD
Study identifier:D1140C00015
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male Japanese Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD7325, Placebo
Sex
Male
Actual Enrollment
48
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jul 2009
Primary Completion Date: -
Estimated Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group 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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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Low dose or placebo, twice daily | Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days |
| Experimental: 2 Low dose or placebo, once daily | Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days |
| Experimental: 3 Middle dose or placebo, twice daily | Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days |
| Experimental: 4 High dose or placebo, once daily | Drug: AZD7325 oral capsule, once or twice daily, 7 days Drug: Placebo oral capsule, once or twice daily, 7 days |
Contacts
Investigators
Principal Investigator
Yuji Kumagai
Kitasato University East Hospital, Kanagawa, Japan
