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

NCT03196206 | Completed Phase 1 FDA Drug

• 1 other identifier: CV010-018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Incidence of Adverse Events (AEs)

  Up to 5 days

• Incidence of Serious Adverse Events ( SAEs)

  Up to 30 days

• Change from baseline in electrocardiogram findings

  Up to 5 days

• Change from baseline in physical examination findings

  Up to 5 days

• Change from baseline in clinical laboratory test findings

  Up to 5 days

Study Arms (3)

Group A

EXPERIMENTAL

Normal Renal Function

Drug: BMS-986177

Group B

EXPERIMENTAL

Moderate Renal Impairment

Drug: BMS-986177

Group C

EXPERIMENTAL

Severe Renal Impairment

Drug: BMS-986177

Interventions

BMS-986177 DRUG

Oral Suspension

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Clinical Pharmacology Of Miami Inc.

Miami, Florida, 33014, United States

Location

Clinical Pharmacology of Miami LLC

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Publications (1)

• 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.

  PMID: 35906349 DERIVED

Related Links

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

MeSH Terms

Conditions

Thrombosis

Interventions

milvexian

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 22, 2017
• Study Start: July 13, 2017
• Primary Completion: March 4, 2018
• Study Completion: March 4, 2018
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

US (3)