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

Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

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

Study Overview

• Status: Withdrawn
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: BMS-986141

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Hepatic Impairment Subjects; Subjects given an oral dose of BMS-986141.	Drug: BMS-986141
Experimental: Moderate Hepatic Impairment Subjects; Subjects given an oral dose of BMS-986141.	Drug: BMS-986141
Experimental: Healthy Subjects; Subjects given an oral dose of BMS-986141.	Drug: BMS-986141

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Anticipated): January 11, 2017
• Primary Completion (Anticipated): May 18, 2017
• Study Completion (Anticipated): July 7, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CV006-030