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

Phase 1

Completed

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

• Registration Number: NCT02982707
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2018-03-01
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild Hepatic Subjects	BMS-986177	Subjects are given a single dose of BMS-986177
Moderate Hepatic Subjects	BMS-986177	Subjects are given a single dose of BMS-986177
Healthy Match Subjects	BMS-986177	Subjects are given a single dose of BMS-986177

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-986177	Up to 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177	Up to 5 days
Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177	Up to 5 days
Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177	Up to 5 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with clinical laboratory abnormalities	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with vital sign abnormalities	Screening until 30 days after discontinuation of dosing or subject's participation

Trial Locations

Locations (3)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States