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

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: BMS-986177

• Registration Number: NCT03196206
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2017-07-13
• Primary Completion: 2018-03-04
• Study Completion: 2018-03-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

Other protocol defined inclusion and exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	BMS-986177	Normal Renal Function
Group B	BMS-986177	Moderate Renal Impairment
Group C	BMS-986177	Severe Renal Impairment

Primary Outcome Measures

Name	Time	Method
AUC from time zero extrapolated to infinite time (AUC (INF))	Up to 5 days	Summary measures of PK parameters
AUC from time zero to time of last quantifiable concentration (AUC (0-T))	Up to 5 days	Summary measures of PK parameters
Maximum observed plasma concentration (Cmax)	Up to 5 days	Measured by plasma concentration

Secondary Outcome Measures

Name	Time	Method
Change from baseline in physical examination findings	Up to 5 days	Measured by investigator assessment
Incidence of Adverse Events (AEs)	Up to 5 days	Safety and tolerability as measured by incidence of AEs
Change from baseline in electrocardiogram findings	Up to 5 days	Measured by investigator assessment
Incidence of Serious Adverse Events ( SAEs)	Up to 30 days	Safety and tolerability as measured by incidence of SAEs
Change from baseline in clinical laboratory test findings	Up to 5 days	Measured by investigator assessment

Trial Locations

Locations (3)

Clinical Pharmacology of Miami LLC; 🇺🇸 Miami, Florida, United States

Clinical Pharmacology Of Miami Inc.; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States