Safety and Tolerability Study of BMS-986177 in Healthy Subjects

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Other: Placebo; Drug: BMS-986177

• Registration Number: NCT02608970
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Study Start: 2015-12-31
• Status Verified: 2017-07
• Primary Completion: 2017-07-23
• Study Completion: 2017-07-23
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo specified dose on specified days
BMS-986177	BMS-986177	BMS-986177 specified dose on specified days

Primary Outcome Measures

Name	Time	Method
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	Approximately 16 days
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	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	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	Approximately 3 days	Adverse event (AE), Serious adverse event (SAE)

Trial Locations

Locations (1)

SGS Belgium NV; 🇧🇪 Antwerpen, Belgium