NCT04225936

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

January 9, 2020

Last Update Submit

October 29, 2021

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (5)

Group A: Mild Hepatic Impairment

EXPERIMENTAL

Part 1

Drug: BMS-986263

Group B: Moderate Hepatic Impairment

EXPERIMENTAL

Part 1

Drug: BMS-986263

Group C: Severe Hepatic Impairment

EXPERIMENTAL

Part 2

Drug: BMS-986263

Group D: Normal Hepatic function (control group)

EXPERIMENTAL

Part 1

Drug: BMS-986263

Group E: Normal Hepatic Function (optional, control group)

EXPERIMENTAL

Part 2

Drug: BMS-986263

Interventions

BMS-986263DRUG

Single Dose

Group A: Mild Hepatic ImpairmentGroup B: Moderate Hepatic ImpairmentGroup C: Severe Hepatic ImpairmentGroup D: Normal Hepatic function (control group)Group E: Normal Hepatic Function (optional, control group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 16, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

November 5, 2021

Record last verified: 2021-10

Locations

US(1)