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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Osaka-city, Osaka, Japan

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	-

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1334&filename=CSR-D3540C00010.pdf
Download
CSR-D3540C00010.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca KK Corporate Communications

81-6-6453-8011

Investigators

Principal Investigator

Michio Yagi

Osaka Pharmacology Clinical Research Hospital