Multiple Dose Japanese Bridging Study
Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
Started Mar 2010
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 25, 2011
June 1, 2010
3 months
January 26, 2010
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Every day for 28 days
Secondary Outcomes (1)
BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))
Days 1, 7, and 14
Study Arms (4)
A1 (BMS-708163)
ACTIVE COMPARATORHealthy Japanese Subjects
A2 (Placebo)
PLACEBO COMPARATORHealthy Japanese Subjects
B1 (BMS-708163)
ACTIVE COMPARATORHealthy Non-Japanese Subjects
B2 (Placebo)
PLACEBO COMPARATORHealthy Non-Japanese Subjects
Interventions
Capsules, Oral, 125 mg, once daily, 14 days
Eligibility Criteria
You may qualify if:
- Healthy Japanese and non-Japanese subjects
- 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
You may not qualify if:
- Serum creatinine values above the normal range
- 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™)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-06