Clinical trial NCT04225936: A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment
Official title: An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* BMI ≥ 18 kg/m\^2 and weight ≥ 50 kg at screening (BMI = weight \[kg\]/height \[m\^2\]).
* Participants with normal hepatic function as judged by the investigator
* Participants with hepatic impairment as judged by the investigator

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
* Any major surgery within 4 weeks of study drug administration
* Previous exposure to BMS-986263

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
measure: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
measure: Total body clearance (CL) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
measure: Volume of distribution (Vz) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
measure: Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
timeFrame: Day 1 to Day 31
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 31 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 59 days or up to 30 days after dosing (whichever is longer)
measure: Incidence of AEs leading to discontinuation
timeFrame: Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).
measure: Number of participants with abnormalities in clinical laboratory assessments
timeFrame: Up to 59 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 59 days
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to 59 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 59 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: