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OpenTrials
Completed

NCT Number: NCT02902679

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986177

Drug

Primary outcomes

  1. To assess the Number of subjects with Adverse events (AEs).

    Time frame: Day -1 - day 3

  2. To assess the Change from baseline in Physical examination parameters.

    Time frame: Day -1 - day 3

  3. To assess the change from baseline in Electrocardiogram (ECG) assessment.

    Time frame: Day -1 - day 3

  4. To assess the change from baseline in clinical laboratory values.

    Time frame: Day -1 - day 3

  5. To assess the change from baseline in vital signs assessment.

    Time frame: Day -1 - day 3

Secondary outcomes

  1. To assess the change from baseline in activated partial thromboplastin time (aPTT).

    Time frame: Day -1 - day 3

  2. To assess the change from baseline in Factor XI clotting activity (FX1c ).

    Time frame: Day -1 - day 3

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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