A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
NCT ID: NCT03000673
Last Updated: 2020-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2017-05-23
2017-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Dose Sequence 1
UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin
Enoxaparin
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)
Specified dose of UFH on specified days
BMS-986177
Specified dose of BMS-986177 on specified day
Dose Sequence 2
BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2
Enoxaparin
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)
Specified dose of UFH on specified days
BMS-986177
Specified dose of BMS-986177 on specified day
Dose Sequence 3
BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1
Enoxaparin
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)
Specified dose of UFH on specified days
BMS-986177
Specified dose of BMS-986177 on specified day
Dose Sequence 4
Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH
Enoxaparin
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)
Specified dose of UFH on specified days
BMS-986177
Specified dose of BMS-986177 on specified day
Interventions
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Enoxaparin
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)
Specified dose of UFH on specified days
BMS-986177
Specified dose of BMS-986177 on specified day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Davita Clinical Research
Lakewood, Colorado, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CV010-010
Identifier Type: -
Identifier Source: org_study_id