Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: BMS-986177

• Registration Number: NCT03362437
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-05
• Primary Completion: 2017-12-28
• Study Completion: 2017-12-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Body mass index 18.0 to 32.0 kg/m2, inclusive
• Women must not be of childbearing potential (cannot become pregnant)

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Exclusion Criteria

• Any significant acute or chronic medical illness
• Head injury in the last 2 years
• History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	BMS-986177	Receive 200 mg BMS-986177 Form A without food
Treatment B	BMS-986177	Receive 200 mg BMS-986177 Form B without food
Treatment C	BMS-986177	Receive 200 mg BMS-986177 Form B with food

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to 3 days	Measured by plasma concentration
AUC from time zero to time of last quantifiable concentration (AUC(0-T))	Up to 3 days	Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF))	Up to 3 days	Measured by plasma concentration

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 12 days	Safety and tolerability as measured by incidence of AEs
Incidence of Serious Adverse Events (SAEs)	Up to 30 days	Safety and tolerability as measured by incidence of SAEs
Number of participants with electrocardiogram abnormalities	Up to 12 days
Number of participants with physical examination abnormalities	Up to 12 days
Number of participants with clinical laboratory abnormalities	Up to 12 days

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington, Nottingham, United Kingdom