Back to resultsStudy to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-708163
BMS-708163
Placebo
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- West Coast Clinical Trials, Llc
- California Clinical Trials Medical Group
- Iberica Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
A1 (BMS-708163)
A2 (Placebo)
B1 (BMS-708163)
B2 (Placebo)
Arm Description
Outcomes
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079819
Brief Title
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1 (BMS-708163)
Arm Type
Active Comparator
Arm Title
A2 (Placebo)
Arm Type
Placebo Comparator
Arm Title
B1 (BMS-708163)
Arm Type
Active Comparator
Arm Title
B2 (Placebo)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsule, Oral, 50 mg, once daily, 1 Day
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsule, Oral, 125 mg, once daily, 14 Days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, 0 mg, One daily, 1 Day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, 0 mg, One daily, 14 Day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Clinical Trials, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
California Clinical Trials Medical Group
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Iberica Clinical Research Center
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163
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