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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: BMS-986141

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985632

CV006-030

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Mild Hepatic Impairment Subjects

Experimental group

Description:

Subjects given an oral dose of BMS-986141.

Treatment:

Drug: BMS-986141

Moderate Hepatic Impairment Subjects

Experimental group

Description:

Subjects given an oral dose of BMS-986141.

Treatment:

Drug: BMS-986141

Healthy Subjects

Experimental group

Description:

Subjects given an oral dose of BMS-986141.

Treatment:

Drug: BMS-986141