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Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01079819
First received: March 2, 2010
Last updated: February 4, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's 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, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079819

Locations
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
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: NCT01079819     History of Changes
Other Study ID Numbers: CN156-029
Study First Received: March 2, 2010
Last Updated: February 4, 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 June 17, 2013