A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy Volunteer

Treatments: Drug: BMS-986165

Study type: Interventional

Funder types: Industry

Identifiers

NCT03890770

2018-002533-38 (EudraCT Number)

IM011-061

Details and patient eligibility

About

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

Enrollment: 44 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:

• Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration)
• Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months
• Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening

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
• Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that 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
• History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 5 patient groups

Normal renal function

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Mild renal disease

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Moderate renal failure

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

Severe renal failure

Experimental group

Description:

Single dose

Treatment:

Drug: BMS-986165

End-stage renal disease requiring dialysis

Experimental group

Description:

Two single doses administered with washout

Treatment:

Drug: BMS-986165