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

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Drug: BMS-986177

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology Of Miami Inc.
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami LLC
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Other protocol defined inclusion and exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Normal Renal Function	Drug: BMS-986177; Oral Suspension
Experimental: Group B; Moderate Renal Impairment	Drug: BMS-986177; Oral Suspension
Experimental: Group C; Severe Renal Impairment	Drug: BMS-986177; Oral Suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30.

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Actual): March 4, 2018
• Study Completion (Actual): March 4, 2018

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CV010-018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No