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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Antithrombotic

Treatments: Drug: unfractionated heparin (UFH); Drug: Enoxaparin; Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03000673

CV010-010

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

32 participants in 4 patient groups

Dose Sequence 1

Active Comparator group

Description:

UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin

Treatment:

Drug: BMS-986177

Drug: unfractionated heparin (UFH)

Drug: Enoxaparin

Dose Sequence 2

Active Comparator group

Description:

BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2

Treatment:

Drug: BMS-986177

Drug: unfractionated heparin (UFH)

Drug: Enoxaparin

Dose Sequence 3

Active Comparator group

Description:

BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1

Treatment:

Drug: BMS-986177

Drug: unfractionated heparin (UFH)

Drug: Enoxaparin

Dose Sequence 4

Active Comparator group

Description:

Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH

Treatment:

Drug: BMS-986177

Drug: unfractionated heparin (UFH)

Drug: Enoxaparin