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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
History of Changes
  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:

U.S. FDA Resources

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
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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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 May 19, 2013