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.

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-02-13

Brief Summary

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

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Detailed Description

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Conditions

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Renal Impairment Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal renal function

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Mild renal disease

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Moderate renal failure

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

Severe renal failure

Single dose

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration

End-stage renal disease requiring dialysis

Two single doses administered with washout

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes