Back to resultsA Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Primary Purpose
Hepatic Impairment
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986141
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
- BMI of 20.0 to 38.0 kg/m2 inclusive
- Participants who a history of normal renal function
- Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
- Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
- Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
- History of recurrent dizziness or fall risk within 4 weeks of study drug administration
- History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
- History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
- Other protocol defined exclusion criteria could apply
Sites / Locations
- Clinical Pharmacology of Miami
- 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 Impairment Subjects
Moderate Hepatic Impairment Subjects
Healthy Subjects
Arm Description
Subjects given an oral dose of BMS-986141.
Subjects given an oral dose of BMS-986141.
Subjects given an oral dose of BMS-986141.
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of BMS-986141
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Secondary Outcome Measures
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
Full Information
NCT ID
NCT02985632
First Posted
December 5, 2016
Last Updated
February 2, 2017
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02985632
Brief Title
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Official Title
Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed.
Study Start Date
January 11, 2017 (Anticipated)
Primary Completion Date
May 18, 2017 (Anticipated)
Study Completion Date
July 7, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild Hepatic Impairment Subjects
Arm Type
Experimental
Arm Description
Subjects given an oral dose of BMS-986141.
Arm Title
Moderate Hepatic Impairment Subjects
Arm Type
Experimental
Arm Description
Subjects given an oral dose of BMS-986141.
Arm Title
Healthy Subjects
Arm Type
Experimental
Arm Description
Subjects given an oral dose of BMS-986141.
Intervention Type
Drug
Intervention Name(s)
BMS-986141
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-986141
Time Frame
Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Time Frame
Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Time Frame
Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Title
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Time Frame
Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Secondary Outcome Measure Information:
Title
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
Time Frame
Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
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, ages 18 to 70 years, inclusive.
BMI of 20.0 to 38.0 kg/m2 inclusive
Participants who a history of normal renal function
Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
History of recurrent dizziness or fall risk within 4 weeks of study drug administration
History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
Other protocol defined exclusion criteria could 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
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
Links:
URL
http://www.bms.com/studyconnect/pages/home.aspx
Description
BMS Clinical Trial Education Resource
URL
http://www.fda.gov/Safety/Recalls/
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
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