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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698282
First Posted: June 17, 2008
Last Update Posted: December 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Condition Intervention Phase
Healthy Drug: AZD1981 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events [ Time Frame: All the time ]
  • Plasma drug concentration [ Time Frame: Every hour ]

Secondary Outcome Measures:
  • Clinical chemistry [ Time Frame: day 1 and 9 ]

Enrollment: 47
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1981
Oral tablet, 250 mg single dose
Experimental: 2 Drug: AZD1981
Suspension, 15, 75, 1000 and 2000 mg
Placebo Comparator: 3 Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese and Caucasian males

Exclusion Criteria:

  • Other clinically relevant disease or disorders
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698282


Locations
United Kingdom
Research Site
Berkshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Elizabeth Hancox Europe Chiltern International Ltd, Berkshire, UK
  More Information

Responsible Party: Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00698282     History of Changes
Other Study ID Numbers: D9831C00005
First Submitted: June 16, 2008
First Posted: June 17, 2008
Last Update Posted: December 1, 2010
Last Verified: November 2010