Single and Multiple Ascending Doses of AZD1981 in Japan - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 16, 2008

Last Updated Date

December 19, 2008

Start Date ^†

July 2008

Current Primary Outcome Measures ^†

Adverse events [ Time Frame: All the time ] [ Designated as safety issue: No ]
Plasma drug concentration [ Time Frame: Every hour ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698282 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Clinical chemistry [ Time Frame: day 1 and 9 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Single and Multiple Ascending Doses of AZD1981 in Japan

Official Title ^†

A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects

Brief Summary

The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study

Condition ^†

Healthy

Intervention ^†

Drug: AZD1981
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

November 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Healthy Japanese and Caucasian males

Exclusion Criteria:

Other clinically relevant disease or disorders

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698282

Responsible Party

Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Principal Investigator:

Elizabeth Hancox

Europe Chiltern International Ltd, Berkshire, UK

Information Provided By

AstraZeneca

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.