A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- BMS-986177
- Conditions
- Thrombosis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
- •Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive
Exclusion Criteria
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- •Any condition that could affect drug absorption
- •Other protocol-defined exclusion criteria could apply
Arms & Interventions
BMS-986177
BMS-986177 specified dose on specified days
Intervention: BMS-986177
Placebo
Placebo specified dose on specified days
Intervention: Placebo
Outcomes
Primary Outcomes
Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time Frame: Approximately 16 days
Tolerability of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time Frame: Approximately 3 days
Safety of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time Frame: Approximately 3 days
Adverse event (AE), Serious adverse event (SAE)
Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time Frame: Approximately 16 days