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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02902679

Enrollment

Registered

2016-09-16

Start date

2016-11-30

Completion date

2017-06-30

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGBMS-986177

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the Change from baseline in Physical examination parameters.	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
To assess the change from baseline in Electrocardiogram (ECG) assessment.	Day -1 - day 3

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026