A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: BMS-986263

• Registration Number: NCT04225936
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-01-16
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group C: Severe Hepatic Impairment	BMS-986263	Part 2
Group D: Normal Hepatic function (control group)	BMS-986263	Part 1
Group B: Moderate Hepatic Impairment	BMS-986263	Part 1
Group A: Mild Hepatic Impairment	BMS-986263	Part 1
Group E: Normal Hepatic Function (optional, control group)	BMS-986263	Part 2

Primary Outcome Measures

Name	Time	Method
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	Day 1 to Day 31
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection	Day 1 to Day 31
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection	Day 1 to Day 31
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection	Day 1 to Day 31
Total body clearance (CL) of components of BMS-986263 for injection	Day 1 to Day 31
Volume of distribution (Vz) of components of BMS-986263 for injection	Day 1 to Day 31

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 31 days
Number of participants with abnormalities in clinical laboratory assessments	Up to 59 days
Number of participants with vital sign abnormalities	Up to 59 days
Incidence of Serious Adverse Events (SAEs)	Up to 59 days or up to 30 days after dosing (whichever is longer)
Number of participants with 12-lead electrocardiogram (ECG) abnormalities	Up to 59 days
Number of participants with physical examination abnormalities	Up to 59 days
Incidence of AEs leading to discontinuation	Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).

Trial Locations

Locations (1)

The Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States