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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: ESRD (End-Stage Renal Disease); Renal Impairment; Thrombosis; Factor XI

Treatments: Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT02902679

CV010-012

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

End Stage Renal Disease Subjects

Experimental group

Description:

Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session

Treatment:

Drug: BMS-986177