A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis

Completed · Phase 1/Phase 2

Conditions studied: Antithrombotic

In brief

To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease treated with hemodialysis

Key facts

Study ID

NCT03000673

Run by

Bristol-Myers Squibb

People needed

32

Starts

2017-05-23

Expected to finish

2017-10-23

Last updated by the study team

2020-12-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with ESRD treated with hemodialysis 3 times a week for at least 3 months prior enrollment.
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
• Women must not be breastfeeding
• Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) BMS-986177 plus 5 half-lives of study treatment (2 days) plus 30 days (duration of ovulatory cycle) for a total of 32 days post-treatment completion
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) BMS-986177 plus 5 half-lives of the study treatment plus 90 days (duration of sperm turnover) for a total of 92 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.

You may not qualify if…

• Subjects receiving dialysis through central venous catheters
• History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease in the past 3 months
• Current or recent (within 3 months of study drug administration) gastrointestinal disease or surgery, which by the judgment of the Investigator, may increase a subject's risk of gastrointestinal bleeding or interfere with absorption of study drug (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrointestinal surgery).
• Any major surgery within 12 weeks of study drug administration
• History of significant head injury within the last 2 years, including subjects with base of skull fractures
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Davita Clinical Research — Lakewood, Colorado, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Davita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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