Clinical trial NCT02902679: A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Factor XI
Renal Impairment
ESRD (End-Stage Renal Disease)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To assess the Number of subjects with Adverse events (AEs).
timeFrame: Day -1 - day 3
measure: To assess the Change from baseline in Physical examination parameters.
timeFrame: Day -1 - day 3
measure: To assess the change from baseline in Electrocardiogram (ECG) assessment.
timeFrame: Day -1 - day 3
measure: To assess the change from baseline in clinical laboratory values.
timeFrame: Day -1 - day 3
measure: To assess the change from baseline in vital signs assessment.
timeFrame: Day -1 - day 3
Secondary outcomes:
measure: To assess the change from baseline in activated partial thromboplastin time (aPTT).
timeFrame: Day -1 - day 3
measure: To assess the change from baseline in Factor XI clotting activity (FX1c ).
timeFrame: Day -1 - day 3
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: