Overview

A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
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