Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2018-03-04

Brief Summary

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Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.

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Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A

Normal Renal Function

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Group B

Moderate Renal Impairment

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Group C

Severe Renal Impairment

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Oral Suspension

Interventions

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BMS-986177

Oral Suspension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
* Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
* Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Females must be of non-childbearing potential

Exclusion Criteria

* Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
* Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes