Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential
• BMI of 20.0 to 38.0 kg/m2, inclusive
• Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
• Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion Criteria:

• Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
• Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
• Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
• Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mild Hepatic Subjects; Subjects are given a single dose of BMS-986177	Drug: BMS-986177; Single oral dose
EXPERIMENTAL: Moderate Hepatic Subjects; Subjects are given a single dose of BMS-986177	Drug: BMS-986177; Single oral dose
EXPERIMENTAL: Healthy Match Subjects; Subjects are given a single dose of BMS-986177	Drug: BMS-986177; Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986177	Up to 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177	Up to 5 days
Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177	Up to 5 days
Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with clinical laboratory abnormalities	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)	Screening until 30 days after discontinuation of dosing or subject's participation
Number of participants with vital sign abnormalities	Screening until 30 days after discontinuation of dosing or subject's participation

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, Chen W, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants. Clin Pharmacokinet. 2022 Jun;61(6):857-867. doi: 10.1007/s40262-022-01110-9. Epub 2022 Mar 9.

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Education Resource

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): September 28, 2018
• Study Completion (ACTUAL): September 28, 2018

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (ESTIMATE): December 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CV010-013

Drug and device information, study documents

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