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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-09-28

Brief Summary

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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

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Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild Hepatic Subjects

Subjects are given a single dose of BMS-986177

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Single oral dose

Moderate Hepatic Subjects

Subjects are given a single dose of BMS-986177

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Single oral dose

Healthy Match Subjects

Subjects are given a single dose of BMS-986177

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Single oral dose

Interventions

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BMS-986177

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes