Single and Multiple Ascending Doses of AZD1981 in Japan
JSAD/JMAD
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
1 other identifier
interventional
47
1 country
1
Brief Summary
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Aug 2008
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedDecember 1, 2010
November 1, 2010
2 months
June 16, 2008
November 30, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse events
All the time
Plasma drug concentration
Every hour
Secondary Outcomes (1)
Clinical chemistry
day 1 and 9
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy Japanese and Caucasian males
You may not qualify if:
- Other clinically relevant disease or disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Berkshire, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Hancox
Europe Chiltern International Ltd, Berkshire, UK
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 17, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
December 1, 2010
Record last verified: 2010-11