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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00828646 |
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male Japanese and healthy elderly male and female Japanese subjects
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: BMS-708163 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
Official Title: | Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Japanese Subjects and a Comparison to Healthy Elderly Japanese Subjects |
Enrollment: | 32 |
Study Start Date: | October 2008 |
Study Completion Date: | July 2009 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BMS-708163 - Panel 1: Experimental
(Age 20-45 years)
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Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
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BMS-708163 - Panel 2: Experimental
(Age 20-45 years)
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Drug: BMS-708163
Capsules, Oral, 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
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BMS-708163 - Panel 3: Experimental
(age 65 or above)
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Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
|
BMS-708163 - Panel 4: Experimental
(age 65 or above)
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Drug: BMS-708163
Capsules, Oral, 75 or 100 mg/day, once daily, 14 days
Drug: Placebo
Capsules, Oral, once daily, 14 days
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN156-012 |
Study First Received: | January 23, 2009 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00828646 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Healthy Subjects |
Healthy |