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

Phase 1

Completed

• Conditions: ESRD (End-Stage Renal Disease); Factor XI; Thrombosis; Renal Impairment
• Interventions: Drug: BMS-986177

• Registration Number: NCT02902679
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-11
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
End Stage Renal Disease Subjects	BMS-986177	Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session

Primary Outcome Measures

Name	Time	Method
To assess the Change from baseline in Physical examination parameters.	Day -1 - day 3
To assess the change from baseline in Electrocardiogram (ECG) assessment.	Day -1 - day 3
To assess the change from baseline in clinical laboratory values.	Day -1 - day 3
To assess the change from baseline in vital signs assessment.	Day -1 - day 3
To assess the Number of subjects with Adverse events (AEs).	Day -1 - day 3

Secondary Outcome Measures

Name	Time	Method
To assess the change from baseline in activated partial thromboplastin time (aPTT).	Day -1 - day 3
To assess the change from baseline in Factor XI clotting activity (FX1c ).	Day -1 - day 3

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States