Clinical trial NCT04634149: A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
Official title: An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate Liver Impairment
Severe Liver Impairment
Keywords: Cirrhosis
Hepatic impairment
Liver impairment
Nonalcoholic steatohepatitis (NASH)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.


Eligibility criteria: Inclusion Criteria:

* Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
* Body mass index (BMI) of 18.0 kg/m\^2 to 40.0 kg/m\^2, inclusive. BMI = weight (kg)/height (m\^2)

Exclusion Criteria:

* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 29 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 29 days
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 29 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 31 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 31 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 31 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 31 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 31 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 29 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 29 days
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))
timeFrame: Up to 29 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0002
state: Florida
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: San Antonio
country: United States
facility: Local Institution - 0001
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: