Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2010-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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A1 (BMS-708163)
Healthy Japanese Subjects
BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
A2 (Placebo)
Healthy Japanese Subjects
Placebo
Capsules, Oral, 0 mg, once daily, 14 days
B1 (BMS-708163)
Healthy Non-Japanese Subjects
BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
B2 (Placebo)
Healthy Non-Japanese Subjects
Placebo
Capsules, Oral, 0 mg, once daily, 14 days
Interventions
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BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
Placebo
Capsules, Oral, 0 mg, once daily, 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
* Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
* BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
* Men ages 20 to 45 years
Exclusion Criteria
* Urine protein or blood levels above the normal range
* Liver function tests above the normal range
* TSH, free T3, or free T4 outside the normal range
* Amylase or lipase levels above the normal range
* Positive Fecal Immunochemical Test (FIT™)
20 Years
45 Years
MALE
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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California Clinical Trials Medical Group
Glendale, California, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CN156-038
Identifier Type: -
Identifier Source: org_study_id
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