Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Multiple Dose Japanese Bridging Study

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01057030
First received: January 26, 2010
Last updated: January 24, 2011
Last verified: June 2010

January 26, 2010
January 24, 2011
March 2010
June 2010   (final data collection date for primary outcome measure)
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs) [ Time Frame: Every day for 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01057030 on ClinicalTrials.gov Archive Site
BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose)) [ Time Frame: Days 1, 7, and 14 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Alzheimer Disease
  • Drug: BMS-708163
    Capsules, Oral, 125 mg, once daily, 14 days
    Other Name: (GAMMA SECRETASE inhibitor)
  • Drug: Placebo
    Capsules, Oral, 0 mg, once daily, 14 days
  • Active Comparator: A1 (BMS-708163)
    Healthy Japanese Subjects
    Intervention: Drug: BMS-708163
  • Placebo Comparator: A2 (Placebo)
    Healthy Japanese Subjects
    Intervention: Drug: Placebo
  • Active Comparator: B1 (BMS-708163)
    Healthy Non-Japanese Subjects
    Intervention: Drug: BMS-708163
  • Placebo Comparator: B2 (Placebo)
    Healthy Non-Japanese Subjects
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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™)
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01057030
CN156-038
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP