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
  Purpose

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


Condition Intervention Phase
Alzheimer Disease
Drug: BMS-708163
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 (BMS-708163)
Healthy Japanese Subjects
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
Other Name: (GAMMA SECRETASE inhibitor)
Placebo Comparator: A2 (Placebo)
Healthy Japanese Subjects
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 14 days
Active Comparator: B1 (BMS-708163)
Healthy Non-Japanese Subjects
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
Other Name: (GAMMA SECRETASE inhibitor)
Placebo Comparator: B2 (Placebo)
Healthy Non-Japanese Subjects
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 14 days

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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™)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057030

Locations
United States, California
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01057030     History of Changes
Other Study ID Numbers: CN156-038
Study First Received: January 26, 2010
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014