A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: End Stage Renal Disease Subjects Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session |
Drug: BMS-986177
|
Outcome Measures
Primary Outcome Measures
- To assess the Number of subjects with Adverse events (AEs). [Day -1 - day 3]
- To assess the Change from baseline in Physical examination parameters. [Day -1 - day 3]
- To assess the change from baseline in Electrocardiogram (ECG) assessment. [Day -1 - day 3]
- To assess the change from baseline in clinical laboratory values. [Day -1 - day 3]
- To assess the change from baseline in vital signs assessment. [Day -1 - day 3]
Secondary Outcome Measures
- To assess the change from baseline in activated partial thromboplastin time (aPTT). [Day -1 - day 3]
- To assess the change from baseline in Factor XI clotting activity (FX1c ). [Day -1 - day 3]
Eligibility Criteria
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
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV010-012