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 |
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
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
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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