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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03362437

CV010-020

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Treatment A

Experimental group

Description:

Receive 200 mg BMS-986177 Form A without food

Treatment:

Drug: BMS-986177

Drug: BMS-986177

Treatment B

Experimental group

Description:

Receive 200 mg BMS-986177 Form B without food

Treatment:

Drug: BMS-986177

Drug: BMS-986177

Treatment C

Experimental group

Description:

Receive 200 mg BMS-986177 Form B with food

Treatment:

Drug: BMS-986177

Drug: BMS-986177