A Study to Evaluate the Pharmacokinetics of BMS-986141 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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2017-07-07

Brief Summary

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An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.

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Detailed Description

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Conditions

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Hepatic Impairment

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 Impairment Subjects

Subjects given an oral dose of BMS-986141.

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Moderate Hepatic Impairment Subjects

Subjects given an oral dose of BMS-986141.

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Healthy Subjects

Subjects given an oral dose of BMS-986141.

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Interventions

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BMS-986141

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
* BMI of 20.0 to 38.0 kg/m2 inclusive
* Participants who a history of normal renal function
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria

* Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
* History of recurrent dizziness or fall risk within 4 weeks of study drug administration
* History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
* History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes