Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163
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
1 other identifier
interventional
32
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2010
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2010
CompletedFirst Posted
Study publicly available on registry
March 3, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 7, 2011
February 1, 2011
8 months
March 2, 2010
February 4, 2011
Conditions
Outcome Measures
Primary Outcomes (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
Study Day 1 through study completion + 30 days
Secondary Outcomes (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
Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2
Study Arms (4)
A1 (BMS-708163)
ACTIVE COMPARATORA2 (Placebo)
PLACEBO COMPARATORB1 (BMS-708163)
ACTIVE COMPARATORB2 (Placebo)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
West Coast Clinical Trials, Llc
Cypress, California, 90630, United States
California Clinical Trials Medical Group
Glendale, California, 91206, United States
Iberica Clinical Research Center
Eatontown, New Jersey, 07724, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2010
First Posted
March 3, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 7, 2011
Record last verified: 2011-02