Single and Multiple Ascending Doses of AZD1981 in Japan (JSAD/JMAD)

November 30, 2010 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy Japanese and Caucasian males

Exclusion Criteria:

  • Other clinically relevant disease or disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD1981
Oral tablet, 250 mg single dose
Drug: AZD1981
Suspension, 15, 75, 1000 and 2000 mg
Experimental: 2
Drug: AZD1981
Oral tablet, 250 mg single dose
Drug: AZD1981
Suspension, 15, 75, 1000 and 2000 mg
Placebo Comparator: 3
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: All the time
All the time
Plasma drug concentration
Time Frame: Every hour
Every hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical chemistry
Time Frame: day 1 and 9
day 1 and 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Elizabeth Hancox, Europe Chiltern International Ltd, Berkshire, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • D9831C00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe