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

Bristol-Myers Squibb12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Thrombosis

Interventions

BMS-986177DRUG

Form A

BMS-986177DRUG

Form B

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Clinical

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax)

Measured by plasma concentration

Time frame: Up to 3 days

AUC from time zero to time of last quantifiable concentration (AUC(0-T))

Measured by plasma concentration

Time frame: Up to 3 days

AUC from time zero extrapolated to infinite time (AUC(INF))

Measured by plasma concentration

Time frame: Up to 3 days

Secondary Outcomes

Incidence of Adverse Events (AEs)

Safety and tolerability as measured by incidence of AEs

Time frame: Up to 12 days

Incidence of Serious Adverse Events (SAEs)

Safety and tolerability as measured by incidence of SAEs

Time frame: Up to 30 days

Number of participants with electrocardiogram abnormalities

Time frame: Up to 12 days

Number of participants with physical examination abnormalities

Time frame: Up to 12 days

Number of participants with clinical laboratory abnormalities

Time frame: Up to 12 days

Data from ClinicalTrials.gov

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