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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00698282 |
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Date of registration:
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16/06/2008 |
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Primary sponsor: |
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Public title:
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Single and Multiple Ascending Doses of AZD1981 in Japan
JSAD/JMAD |
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Scientific title:
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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 |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00698282 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Elizabeth Hancox |
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Address:
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Telephone:
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Email:
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Affiliation:
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Europe Chiltern International Ltd, Berkshire, UK |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy Japanese and Caucasian males
Exclusion Criteria:
- Other clinically relevant disease or disorders
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: AZD1981
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Drug: Placebo
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Primary Outcome(s)
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Adverse events
[Time Frame: All the time]
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Plasma drug concentration
[Time Frame: Every hour]
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Secondary Outcome(s)
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Clinical chemistry
[Time Frame: day 1 and 9]
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Secondary ID(s)
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D9831C00005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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