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

NCT02985632 | Withdrawn Phase 1

• 1 other identifier: CV006-030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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)

Study Arms (3)

Mild Hepatic Impairment Subjects

EXPERIMENTAL

Subjects given an oral dose of BMS-986141.

Drug: BMS-986141

Moderate Hepatic Impairment Subjects

EXPERIMENTAL

Subjects given an oral dose of BMS-986141.

Drug: BMS-986141

Healthy Subjects

EXPERIMENTAL

Subjects given an oral dose of BMS-986141.

Drug: BMS-986141

Interventions

BMS-986141 DRUG

Healthy Subjects; Mild Hepatic Impairment Subjects; Moderate Hepatic Impairment Subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Education Resource
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

BMS-986141

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: January 11, 2017
• Primary Completion: May 18, 2017
• Study Completion: July 7, 2017
• Last Updated: February 6, 2017

Record last verified: 2017-02

Locations

US (3)