Safety, tolerability and pharmacokinetics of inhaled doses of AZD4818 in healthy Japanese male volunteers
Study identifier:D3540C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, placebo-controlled single-blind, single-centre Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD4818, Placebo
Sex
Male
Actual Enrollment
30
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: 01 May 2008
Study Completion Date: 01 May 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD4818 | Drug: AZD4818 Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days |
| Placebo Comparator: 2 | - |
Contacts
Investigators
Principal Investigator
Michio Yagi
Osaka Pharmacology Clinical Research Hospital
