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

NCT02902679 | Completed Phase 1

• 1 other identifier: CV010-012
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis; Factor XI; Renal Impairment; ESRD (End-Stage Renal Disease)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (1)

End Stage Renal Disease Subjects

EXPERIMENTAL

Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session

Drug: BMS-986177

Interventions

BMS-986177 DRUG

End Stage Renal Disease Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

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

MeSH Terms

Conditions

Thrombosis; Renal Insufficiency; Renal Insufficiency, Chronic

Interventions

milvexian

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 16, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

US (1)