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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:11/16/2018
Start Date:May 23, 2017
End Date:October 23, 2017

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A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis

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


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
3
sites
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Lakewood, Colorado 80228
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Lakewood, CO
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