An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-11-30

Brief Summary

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The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

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Detailed Description

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Conditions

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Liver Dysfunction Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal liver function

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Mild liver impairment

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Moderate liver impairment

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Severe liver impairment

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Interventions

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BMS-986165

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.73 m2 for participants

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
* History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
* Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes