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OpenTrials
Completed

NCT Number: NCT04225936

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

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

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Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986263

Drug

Single Dose

Primary outcomes

  1. Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection

    Time frame: Day 1 to Day 31

  2. 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

    Time frame: Day 1 to Day 31

  3. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection

    Time frame: Day 1 to Day 31

  4. Total body clearance (CL) of components of BMS-986263 for injection

    Time frame: Day 1 to Day 31

  5. Volume of distribution (Vz) of components of BMS-986263 for injection

    Time frame: Day 1 to Day 31

  6. Terminal elimination half-life (T-Half) of components of BMS-986263 for injection

    Time frame: Day 1 to Day 31

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 31 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 59 days or up to 30 days after dosing (whichever is longer)

  3. Incidence of AEs leading to discontinuation

    Time frame: Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).

  4. Number of participants with abnormalities in clinical laboratory assessments

    Time frame: Up to 59 days

  5. Number of participants with vital sign abnormalities

    Time frame: Up to 59 days

  6. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to 59 days

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 59 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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