A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

Phase 1

Withdrawn

• Conditions: Hepatic Impairment
• Interventions: Drug: BMS-986141

• Registration Number: NCT02985632
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Study Start: 2017-01-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06
• Primary Completion: 2017-05-18
• Study Completion: 2017-07-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)
• Other protocol defined exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	BMS-986141	Subjects given an oral dose of BMS-986141.
Moderate Hepatic Impairment Subjects	BMS-986141	Subjects given an oral dose of BMS-986141.
Mild Hepatic Impairment Subjects	BMS-986141	Subjects given an oral dose of BMS-986141.

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) of BMS-986141	Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141	Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141	Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141	Days 1-7 (healthy) Days 1-10 (heaptic Impairment)

Secondary Outcome Measures

Name	Time	Method
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.	Days 1-7 (healthy) Days 1-10 (heaptic Impairment)

Trial Locations

Locations (3)

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

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

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