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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Liver Dysfunction

Treatments: Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03890809

2018-002534-20 (EudraCT Number)

IM011-062

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Normal liver function

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Mild liver impairment

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Moderate liver impairment

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Severe liver impairment

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165