NCT02982707

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 15, 2016

Last Update Submit

November 12, 2018

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Mild Hepatic Subjects

EXPERIMENTAL

Subjects are given a single dose of BMS-986177

Drug: BMS-986177

Moderate Hepatic Subjects

EXPERIMENTAL

Subjects are given a single dose of BMS-986177

Drug: BMS-986177

Healthy Match Subjects

EXPERIMENTAL

Subjects are given a single dose of BMS-986177

Drug: BMS-986177

Interventions

BMS-986177DRUG

Single oral dose

Healthy Match SubjectsMild Hepatic SubjectsModerate Hepatic Subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Publications (1)

  • 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.

    PMID: 35262846DERIVED

Related Links

MeSH Terms

Conditions

Thrombosis

Interventions

milvexian

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

December 5, 2016

Study Start

March 1, 2018

Primary Completion

September 28, 2018

Study Completion

September 28, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(3)