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

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.
 
ClinicalTrials.gov Identifier: NCT00698282
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD1981 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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



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

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


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

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
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United Kingdom
Research Site
Berkshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Elizabeth Hancox Europe Chiltern International Ltd, Berkshire, UK
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Responsible Party: Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00698282    
Other Study ID Numbers: D9831C00005
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010