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

NCT ID: NCT04225936

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Mild Hepatic Impairment

Part 1

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

Single Dose

Group B: Moderate Hepatic Impairment

Part 1

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

Single Dose

Group C: Severe Hepatic Impairment

Part 2

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

Single Dose

Group D: Normal Hepatic function (control group)

Part 1

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

Single Dose

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

Part 2

Group Type EXPERIMENTAL

BMS-986263

Intervention Type DRUG

Single Dose

Interventions

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BMS-986263

Single Dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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The Texas Liver Institute

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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IM025-015

Identifier Type: -

Identifier Source: org_study_id