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Trial record 1 of 1 for:    NCT01079819
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Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01079819
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : February 7, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: BMS-708163 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A1 (BMS-708163) Drug: BMS-708163
Capsule, Oral, 50 mg, once daily, 1 Day

Placebo Comparator: A2 (Placebo) Drug: Placebo
Capsule, Oral, 0 mg, One daily, 1 Day

Active Comparator: B1 (BMS-708163) Drug: BMS-708163
Capsule, Oral, 125 mg, once daily, 14 Days

Placebo Comparator: B2 (Placebo) Drug: Placebo
Capsule, Oral, 0 mg, One daily, 14 Day

Primary Outcome Measures :
  1. Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance [ Time Frame: Study Day 1 through study completion + 30 days ]

Secondary Outcome Measures :
  1. Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data [ Time Frame: Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion Criteria:

  • Women of childbearing potential
  • Gastrointestinal disorders
  • Bleeding disorders
  • Peptic ulcer disease
  • Abnormal ECG
  • Abnormal Clinical laboratory tests
  • Abnormal Thyroid
  • Congestive heart failure
  • Cholecystectomy
  • Asthma
  • Hypertension
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01079819

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United States, California
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
California Clinical Trials Medical Group
Glendale, California, United States, 91206
United States, New Jersey
Iberica Clinical Research Center
Eatontown, New Jersey, United States, 07724
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01079819    
Other Study ID Numbers: CN156-029
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: February 7, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders