Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to 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

NCT02982707

CV010-013

Details and patient eligibility

About

A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential
• BMI of 20.0 to 38.0 kg/m2, inclusive
• Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
• Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion criteria

• Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
• Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
• Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
• Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Mild Hepatic Subjects

Experimental group

Description:

Subjects are given a single dose of BMS-986177

Treatment:

Drug: BMS-986177

Moderate Hepatic Subjects

Experimental group

Description:

Subjects are given a single dose of BMS-986177

Treatment:

Drug: BMS-986177

Healthy Match Subjects

Experimental group

Description:

Subjects are given a single dose of BMS-986177

Treatment:

Drug: BMS-986177