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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986177
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Pharmacology of Miami
  • Orlando Clinical Research Center
  • Texas Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mild Hepatic Subjects

Moderate Hepatic Subjects

Healthy Match Subjects

Arm Description

Subjects are given a single dose of BMS-986177

Subjects are given a single dose of BMS-986177

Subjects are given a single dose of BMS-986177

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation
Number of participants with clinical laboratory abnormalities
Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)
Number of participants with vital sign abnormalities

Full Information

First Posted
November 15, 2016
Last Updated
November 12, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02982707
Brief Title
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Official Title
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Hepatic Subjects
Arm Type
Experimental
Arm Description
Subjects are given a single dose of BMS-986177
Arm Title
Moderate Hepatic Subjects
Arm Type
Experimental
Arm Description
Subjects are given a single dose of BMS-986177
Arm Title
Healthy Match Subjects
Arm Type
Experimental
Arm Description
Subjects are given a single dose of BMS-986177
Intervention Type
Drug
Intervention Name(s)
BMS-986177
Intervention Description
Single oral dose
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-986177
Time Frame
Up to 5 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177
Time Frame
Up to 5 days
Title
Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177
Time Frame
Up to 5 days
Title
Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation
Time Frame
Screening until 30 days after discontinuation of dosing or subject's participation
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Screening until 30 days after discontinuation of dosing or subject's participation
Title
Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)
Time Frame
Screening until 30 days after discontinuation of dosing or subject's participation
Title
Number of participants with vital sign abnormalities
Time Frame
Screening until 30 days after discontinuation of dosing or subject's participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35262846
Citation
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.
Results Reference
derived
Links:
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Education Resource

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

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