Clinical trial NCT02985632: A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Official title: Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986141
timeFrame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
timeFrame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
timeFrame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
timeFrame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Secondary outcomes:
measure: Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
timeFrame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: