Back to resultsA Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Primary Purpose
Thrombosis, Factor XI, Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986177
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months.
- Clinical, ECG, and laboratory findings consistent with renal dysfunction
- BMI of 18.0 to 38.0 kg/m2 inclusive
- Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose)
- Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
Exclusion Criteria:
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
- Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising
- Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug
- Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis)
- Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
- Other protocol defined exclusion criteria could apply
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
End Stage Renal Disease Subjects
Arm Description
Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session
Outcomes
Primary Outcome Measures
To assess the Number of subjects with Adverse events (AEs).
To assess the Change from baseline in Physical examination parameters.
To assess the change from baseline in Electrocardiogram (ECG) assessment.
To assess the change from baseline in clinical laboratory values.
To assess the change from baseline in vital signs assessment.
Secondary Outcome Measures
To assess the change from baseline in activated partial thromboplastin time (aPTT).
To assess the change from baseline in Factor XI clotting activity (FX1c ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02902679
Brief Title
A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Official Title
An Open-label Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
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-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Factor XI, Renal Impairment, ESRD (End-Stage Renal Disease)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End Stage Renal Disease Subjects
Arm Type
Experimental
Arm Description
Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session
Intervention Type
Drug
Intervention Name(s)
BMS-986177
Primary Outcome Measure Information:
Title
To assess the Number of subjects with Adverse events (AEs).
Time Frame
Day -1 - day 3
Title
To assess the Change from baseline in Physical examination parameters.
Time Frame
Day -1 - day 3
Title
To assess the change from baseline in Electrocardiogram (ECG) assessment.
Time Frame
Day -1 - day 3
Title
To assess the change from baseline in clinical laboratory values.
Time Frame
Day -1 - day 3
Title
To assess the change from baseline in vital signs assessment.
Time Frame
Day -1 - day 3
Secondary Outcome Measure Information:
Title
To assess the change from baseline in activated partial thromboplastin time (aPTT).
Time Frame
Day -1 - day 3
Title
To assess the change from baseline in Factor XI clotting activity (FX1c ).
Time Frame
Day -1 - day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months.
Clinical, ECG, and laboratory findings consistent with renal dysfunction
BMI of 18.0 to 38.0 kg/m2 inclusive
Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose)
Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
Exclusion Criteria:
History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising
Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug
Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis)
Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
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
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
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 Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
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