A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Completed · Phase 1
Conditions studied: Thrombosis, Factor XI, Renal Impairment, ESRD (End-Stage Renal Disease)
In brief
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.
Key facts
- Study ID
- NCT02902679
- Run by
- Bristol-Myers Squibb
- People needed
- 6
- Starts
- 2016-11-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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