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

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

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

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: BMS-986263

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78215
      • The Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A: Mild Hepatic Impairment; Part 1	Drug: BMS-986263; Single Dose
EXPERIMENTAL: Group B: Moderate Hepatic Impairment; Part 1	Drug: BMS-986263; Single Dose
EXPERIMENTAL: Group C: Severe Hepatic Impairment; Part 2	Drug: BMS-986263; Single Dose
EXPERIMENTAL: Group D: Normal Hepatic function (control group); Part 1	Drug: BMS-986263; Single Dose
EXPERIMENTAL: Group E: Normal Hepatic Function (optional, control group); Part 2	Drug: BMS-986263; Single Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 to the time of the last quantifiable concentration (AUC(0-T)) 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
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection	Day 1 to Day 31

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2020
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: IM025-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No