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

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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