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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02985632
• Other study ID #: CV006-030
• Status: Withdrawn
• Phase: Phase 1
• First received: December 5, 2016
• Last updated: February 2, 2017
• Start date: January 11, 2017
• Est. completion date: July 7, 2017

Study information

• Verified date: February 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 7, 2017
• Est. primary completion date: May 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• BMS-986141

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Clinical Research Center	Orlando	Florida
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986141		Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Primary	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)
Primary	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)
Primary	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	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)

External Links

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