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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902679
• Other study ID #: CV010-012
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2016
• Last updated: July 25, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ESRD (End-Stage Renal Disease)
• Factor XI
• Kidney Failure, Chronic
• Renal Impairment
• Renal Insufficiency
• Thrombosis

Intervention

Drug:
• BMS-986177

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the Number of subjects with Adverse events (AEs).		Day -1 - day 3
Primary	To assess the Change from baseline in Physical examination parameters.		Day -1 - day 3
Primary	To assess the change from baseline in Electrocardiogram (ECG) assessment.		Day -1 - day 3
Primary	To assess the change from baseline in clinical laboratory values.		Day -1 - day 3
Primary	To assess the change from baseline in vital signs assessment.		Day -1 - day 3
Secondary	To assess the change from baseline in activated partial thromboplastin time (aPTT).		Day -1 - day 3
Secondary	To assess the change from baseline in Factor XI clotting activity (FX1c ).		Day -1 - day 3

External Links

•   BMS Clinical Trial Education Resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form