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

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis; Renal Impairment; Factor XI; ESRD (End-Stage Renal Disease)
• Intervention / Treatment: Drug: BMS-986177

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: End Stage Renal Disease Subjects; Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session	Drug: BMS-986177

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the Number of subjects with Adverse events (AEs).	Day -1 - day 3
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Embolism and Thrombosis; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Thrombosis
• Other Study ID Numbers: CV010-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No