Single and Multiple Ascending Doses of AZD1981 in Japan

NCT00698282 — Phase 1, Completed, 47 participants, AstraZeneca

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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

Registry	NCT00698282, acronym JSAD/JMAD
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	47 (Actual)
Sponsor	AstraZeneca (Industry)
Conditions	Healthy
Interventions	AZD1981, Placebo (Drug)
Dates	start 2008-08-01, primary completion 2008-10-01, completion 2008-10-01, first posted 2008-06-17, last updated 2010-12-01
Locations	1 site in United Kingdom

-Summary

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

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+Arms and interventions

Arm	Type	Interventions
1	Experimental	Drug: AZD1981
2	Experimental	Drug: AZD1981
3	Placebo comparator	Drug: Placebo

AZD1981 (Drug): Oral tablet, 250 mg single dose
AZD1981 (Drug): Suspension, 15, 75, 1000 and 2000 mg
Placebo (Drug)

+Outcome measures

Primary outcomes

Adverse events [All the time]
Plasma drug concentration [Every hour]

Secondary outcomes

Clinical chemistry [day 1 and 9]

+Eligibility

Sex: Male, ages: 20 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy Japanese and Caucasian males

Exclusion Criteria:

* Other clinically relevant disease or disorders

+Locations (1)

Facility	City	Country	Status
Research Site	Berkshire	United Kingdom

+Investigators

Elizabeth Hancox, Principal investigator, Europe Chiltern International Ltd, Berkshire, UK