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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03000673
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arms: 4
• Actual Duration (Months): 5
• Patients Per Site: 10.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Antithrombotic	Drug: Enoxaparin; Drug: unfractionated heparin (UFH); Drug: BMS-986177	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis
• Actual Study Start Date: May 23, 2017
• Actual Primary Completion Date: Oct 23, 2017
• Actual Study Completion Date: Oct 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dose Sequence 1 UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin	Drug: Enoxaparin; Specified dose of Enoxaparin on specified days; Drug: unfractionated heparin (UFH); Specified dose of UFH on specified days; Drug: BMS-986177; Specified dose of BMS-986177 on specified day
Active Comparator: Dose Sequence 2 BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2	Drug: Enoxaparin; Specified dose of Enoxaparin on specified days; Drug: unfractionated heparin (UFH); Specified dose of UFH on specified days; Drug: BMS-986177; Specified dose of BMS-986177 on specified day
Active Comparator: Dose Sequence 3 BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1	Drug: Enoxaparin; Specified dose of Enoxaparin on specified days; Drug: unfractionated heparin (UFH); Specified dose of UFH on specified days; Drug: BMS-986177; Specified dose of BMS-986177 on specified day
Active Comparator: Dose Sequence 4 Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH	Drug: Enoxaparin; Specified dose of Enoxaparin on specified days; Drug: unfractionated heparin (UFH); Specified dose of UFH on specified days; Drug: BMS-986177; Specified dose of BMS-986177 on specified day

Outcome Measures

Primary Outcome Measures

1. The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death [From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)]

   Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death

2. The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.]

   HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85*PRE-RX; HEMATOCRIT HCT % LOW < 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; HIGH > 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF LLN <= PRE-RX <= ULN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF LLN <= PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW < 1.5 IF PRE-RX IS MISSING; < 1.5 IF PRE-RX >= 1.5; < 0.85*PRE-RX IF; PRE-RX < 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW < 0.75; HIGH > 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH > 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH > 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH > 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH > 1.5*ULN; APTT APTT SEC HIGH > 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH > 1.5*ULN;

3. The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.]

   LIVER & KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.2*PRE-RX IF PRE-RX > ULN; CREATININE CREAT MG/DL HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.33*PRE-RX IF PRE-RX > ULN;

4. The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge]

   ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW < 0.95*LLN IF PRE-RX IS MISSING; < 0.95*LLN IF PRE-RX >= LLN; < 0.95*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.05*ULN IF PRE-RX IS MISSING; > 1.05*ULN IF PRE-RX <= ULN; > 1.05*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN;

5. The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.]

   ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; MAGNESIUM, SERUM MG MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN

6. The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.]

   GLUCOSE, FASTING SERUM GLUCF MG/DL LOW < 0.8*LLN IF PRE-RX IS MISSING; < 0.8*LLN IF PRE-RX >= LLN; < 0.8*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.3*ULN IF PRE-RX IS MISSING > 1.3*ULN IF PRE-RX <= ULN; > 2*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PROTEIN, TOTAL TPRO G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; ALBUMIN ALB G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; CREATINE KINASE (CK) CK U/L HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; URIC ACID URIC MG/DL HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; LACTATE DEHYDR (LD) LD U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN

7. The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies [At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.]

   URINALYSIS I; BLOOD, URINE UBLD N/A HIGH >= 2 IF PRE-RX IS MISSING; >= 2 IF PRE-RX < 1; >= 2 IF PRE-RX >= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE

8. The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate [Days -3 to -1, Days 1, 5, 8, and 12.]

   Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

9. The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate [Days -3 to -1, Days 1, 5, 8, and 12.]

   Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

10. The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate [Days -3 to -1, Days 1, 5, 8, and 12.]

    Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

11. The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate [Days -3 to -1, Days 1, 5, 8, and 12.]

    Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

12. The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate [Days -3 to -1, Days 1, 5, 8, and 12]

    QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

13. The Change From Baseline in Vital Signs: Diastolic Blood Pressure [Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15]

14. The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg) [Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15]

15. The Change From Baseline in Vital Signs: Heart Rate (Beats/Min) [Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15]

Secondary Outcome Measures

1. Pharmacokinetic Parameters of BMS-986177: Cmax [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   Cmax: Maximum observed plasma concentration

2. Pharmacokinetic Parameters of BMS-986177: Tmax [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   Time of maximum observed plasma concentration

3. Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24) [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours

4. Pharmacokinetic Parameters of BMS-986177: fu [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   Fraction of unbound drug

5. Pharmacokinetic Parameters of BMS-986177: Cmaxfu [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   Maximum observed plasma concentration of free drug

6. Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug

7. Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7) [Either Day 1, 5, 8, or 12 depending on the randomization sequence]

   AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis. Determined from blood samples entering and exiting the dialyzer)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Davita Clinical Research	Lakewood	Colorado	United States	80228
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809
3	Davita Clinical Research	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Study Protocol - Sep 6, 2017
• Statistical Analysis Plan - Nov 2, 2017

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03000673
• Other Study ID Numbers: CV010-010
• First Posted: Dec 22, 2016
• Last Update Posted: Dec 29, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heparin; Enoxaparin; Calcium heparin

Study Results

Participant Flow

Pre-assignment Detail	32 participants were randomized and treated.

Arm/Group Title	Sequence ABCD	Sequence BDAC	Sequence CADB	Sequence DCBA
Arm/Group Description	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
Period Title: Overall Study
STARTED	7	9	7	9
COMPLETED	6	9	7	9
NOT COMPLETED	1	0	0	0

Baseline Characteristics

Arm/Group Title	Seq ABCD	Seq BDAC	Seq CADB	Seq DCBA	Total
Arm/Group Description	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.	Total of all reporting groups
Overall Participants	7	9	7	9	32
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.1 (7.3)	55.6 (6.6)	52.0 (12.4)	51.7 (9.9)	53.6 (8.9)
Sex: Female, Male (Count of Participants)
Female	1 14.3%	5 55.6%	3 42.9%	3 33.3%	12 37.5%
Male	6 85.7%	4 44.4%	4 57.1%	6 66.7%	20 62.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	7 100%	9 100%	7 100%	9 100%	32 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Number) [Number]
White	1 14.3%	0 0%	1 14.3%	1 11.1%	3 9.4%
Black or African American	6 85.7%	9 100%	6 85.7%	8 88.9%	29 90.6%

Outcome Measures

1. Primary Outcome

Title	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Description	Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death
Time Frame	From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Adverse Events	4 57.1%	4 44.4%	3 42.9%	2 22.2%
Serious Adverse Events	0 0%	0 0%	0 0%	0 0%
Adverse Events Leading to Discontinuations	0 0%	0 0%	0 0%	0 0%
Deaths	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Description	HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85*PRE-RX; HEMATOCRIT HCT % LOW < 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; HIGH > 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF LLN <= PRE-RX <= ULN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF LLN <= PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW < 1.5 IF PRE-RX IS MISSING; < 1.5 IF PRE-RX >= 1.5; < 0.85*PRE-RX IF; PRE-RX < 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW < 0.75; HIGH > 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH > 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH > 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH > 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH > 1.5*ULN; APTT APTT SEC HIGH > 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH > 1.5*ULN;
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Hematology I Hemoglobin (G/DL) Abnormal low	3 42.9%	3 33.3%	2 28.6%	1 11.1%
Hematocrit (%) Abnormal low	3 42.9%	4 44.4%	2 28.6%	2 22.2%
Platelet Count (X10*9 C/L) Abnormal low	1 14.3%	1 11.1%	2 28.6%	1 11.1%
Leukocytes (X10*3 C/UL) Abnormal low	2 28.6%	1 11.1%	0 0%	2 22.2%
Leukocytes (X10*3 C/UL): Abnormal high	0 0%	0 0%	1 14.3%	1 11.1%
Neutrophils (Absolute) (X10*3 C/UL)	0 0%	0 0%	2 28.6%	1 11.1%
Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	3 42.9%	4 44.4%	3 42.9%	5 55.6%
Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Basophils (Absolute) (X10*3 C/UL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Eosinophils (Absolute) (X10*3 C/UL)	1 14.3%	1 11.1%	2 28.6%	1 11.1%
Prothrombin time (PT) (sec): Abnormal high	1 14.3%	1 11.1%	2 28.6%	0 0%
APTT (sec): Abnormal high	4 57.1%	25 277.8%	1 14.3%	0 0%
APTT (sec): Not reported	1 14.3%	0 0%	0 0%	1 11.1%
INR (fraction): Abnormal high	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Description	LIVER & KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.2*PRE-RX IF PRE-RX > ULN; CREATININE CREAT MG/DL HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.33*PRE-RX IF PRE-RX > ULN;
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
ALP (U/L) Abnormal high	0 0%	0 0%	0 0%	1 11.1%
AST (U/L) Abnormal high	0 0%	0 0%	0 0%	0 0%
AST (U/L) Not reported	0 0%	0 0%	1 14.3%	0 0%
ALT (U/L) Abnormal high	0 0%	0 0%	1 14.3%	0 0%
Bilirubin, Total (MG/DL) Abnormal high	0 0%	0 0%	1 14.3%	0 0%
Bilirubin, Direct (MG/DL) Abnormal high	1 14.3%	1 11.1%	1 14.3%	3 33.3%
Bilirubin, Direct (MG/DL), Not reported	1 14.3%	0 0%	1 14.3%	0 0%
Blood Urea Nitrogen (MG/DL) Abnormal high	0 0%	1 11.1%	1 14.3%	0 0%
Creatinine (MG/DL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Creatinine (MG/DL) Not reported	1 14.3%	0 0%	0 0%	1 11.1%

4. Primary Outcome

Title	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Description	ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW < 0.95*LLN IF PRE-RX IS MISSING; < 0.95*LLN IF PRE-RX >= LLN; < 0.95*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.05*ULN IF PRE-RX IS MISSING; > 1.05*ULN IF PRE-RX <= ULN; > 1.05*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN;
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Sodium, Serum (MEQ/L), Abnormal low	0 0%	0 0%	0 0%	0 0%
Sodium, Serum (MEQ/L), Abnormal high	0 0%	0 0%	0 0%	0 0%
Potassium, Serum (MEQ/L), Abnormal low	0 0%	0 0%	0 0%	0 0%
Potassium, Serum (MEQ/L), Abnormal high	0 0%	1 11.1%	1 14.3%	1 11.1%
Potassium, Serum (MEQ/L), Not reported	0 0%	0 0%	1 14.3%	0 0%
Chloride, Serum (MEQ/L) Abnormal low	0 0%	0 0%	0 0%	0 0%
Chloride, Serum (MEQ/L) Abnormal high	0 0%	0 0%	0 0%	0 0%
Chloride, Serum (MEQ/L) Not reported	0 0%	0 0%	0 0%	1 11.1%

5. Primary Outcome

Title	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Description	ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; MAGNESIUM, SERUM MG MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Calcium, Total (MG/DL) Abnormal low	0 0%	0 0%	0 0%	1 11.1%
Calcium, Total (MG/DL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Phosphorus, Inorganic (MG/DL) Abnormal low	0 0%	1 11.1%	1 14.3%	2 22.2%
Phosphorus, Inorganic (MG/DL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Magnesium, Serum (MEQ/L), Abnormal low	0 0%	1 11.1%	0 0%	1 11.1%
Magnesium, Serum (MEQ/L), Abnormal high	0 0%	0 0%	0 0%	0 0%
Magnesium, Serum (MEQ/L), Not reported	0 0%	0 0%	1 14.3%	0 0%

6. Primary Outcome

Title	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Description	GLUCOSE, FASTING SERUM GLUCF MG/DL LOW < 0.8*LLN IF PRE-RX IS MISSING; < 0.8*LLN IF PRE-RX >= LLN; < 0.8*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.3*ULN IF PRE-RX IS MISSING > 1.3*ULN IF PRE-RX <= ULN; > 2*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PROTEIN, TOTAL TPRO G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; ALBUMIN ALB G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; CREATINE KINASE (CK) CK U/L HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; URIC ACID URIC MG/DL HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; LACTATE DEHYDR (LD) LD U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Glucose, Fasting serum (MG/DL) Abnormal low	0 0%	0 0%	1 14.3%	1 11.1%
Glucose, Fasting serum (MG/DL) Abnormal high	2 28.6%	2 22.2%	4 57.1%	4 44.4%
Protein, Total (G/DL) Abnormal low	0 0%	0 0%	1 14.3%	1 11.1%
Protein, Total (G/DL) Abnormal high	0 0%	0 0%	0 0%	0 0%
Albumin (G/DL) Abnormal low	0 0%	0 0%	1 14.3%	2 22.2%
Creatine Kinase (CK) (U/L) Abnormal high	0 0%	0 0%	0 0%	0 0%
Creatine Kinase (CK) (U/L) Not reported	0 0%	0 0%	1 14.3%	0 0%
Uric Acid (MG/DL) Abnormal High	0 0%	0 0%	0 0%	0 0%
LD (U/L) Abnormal high	0 0%	0 0%	3 42.9%	0 0%
LD (U/L) Not reported	0 0%	0 0%	1 14.3%	0 0%

7. Primary Outcome

Title	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
Description	URINALYSIS I; BLOOD, URINE UBLD N/A HIGH >= 2 IF PRE-RX IS MISSING; >= 2 IF PRE-RX < 1; >= 2 IF PRE-RX >= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE
Time Frame	At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

Outcome Measure Data

Analysis Population Description

All treated participants with evaluable test results

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Blood, Urine (N/A) Abnormal high	1 14.3%	1 11.1%	0 0%	0 0%
Occult Blood Screen, Feces (N/A) Abnormal high	0 0%	0 0%	0 0%	0 0%

8. Primary Outcome

Title	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Description	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Time Frame	Days -3 to -1, Days 1, 5, 8, and 12.

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Day 1	1.8 (8.6)	1.4 (5.1)	0.4 (8.1)	-0.1 (5.4)
Day 5	-2.1 (6.9)	2.0 (10.8)	2.0 (8.1)	1.6 (5.9)
Day 8	0.0 (6.9)	-2.8 (6.1)	2.3 (4.7)	4.0 (9.8)
Day 12	0.4 (6.0)	3.9 (9.5)	0.8 (2.9)	1.4 (9.5)

9. Primary Outcome

Title	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Description	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Time Frame	Days -3 to -1, Days 1, 5, 8, and 12.

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Day 1	-1.3 (9.9)	-25.0 (67.8)	-6.9 (12.6)	13.6 (26.3)
Day 5	12.6 (21.2)	-5.8 (8.9)	-5.1 (11.8)	-25.4 (66.5)
Day 8	-1.2 (19.3)	12.7 (25.5)	-22.6 (70.3)	-3.4 (27.2)
Day 12	-27.7 (67.9)	-5.6 (8.7)	8.8 (12.4)	-2.6 (8.7)

10. Primary Outcome

Title	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Description	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Time Frame	Days -3 to -1, Days 1, 5, 8, and 12.

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Day 1	-1.1 (6.7)	5.7 (6.2)	-0.2 (3.3)	-3.1 (11.0)
Day 5	-0.3 (14.8)	-0.2 (4.6)	-0.2 (4.6)	0.6 (4.8)
Day 8	-0.2 (4.2)	-1.8 (8.8)	-0.7 (6.0)	0.3 (8.6)
Day 12	0.9 (6.3)	-0.1 (9.3)	-0.7 (9.7)	2.0 (7.0)

11. Primary Outcome

Title	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Description	Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Time Frame	Days -3 to -1, Days 1, 5, 8, and 12.

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Day 1	-3.7 (22.2)	-1.6 (20.8)	-3.1 (24.0)	3.9 (23.2)
Day 5	8.4 (19.3)	-7.4 (20.1)	-2.8 (22.0)	5.6 (15.9)
Day 8	-1.8 (21.3)	12.0 (11.9)	-3.6 (24.0)	-7.4 (26.8)
Day 12	0.7 (20.1)	-14.9 (28.2)	-0.7 (10.8)	-2.2 (20.4)

12. Primary Outcome

Title	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Description	QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Time Frame	Days -3 to -1, Days 1, 5, 8, and 12

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
Day 1	-3.2 (15.3)	1.7 (13.5)	-1.0 (16.5)	5.7 (15.7)
Day 5	5.1 (7.6)	-4.9 (11.8)	-0.6 (13.1)	9.9 (14.7)
Day 8	-1.3 (17.1)	6.2 (6.7)	0.3 (19.7)	-2.1 (18.5)
Day 12	2.1 (15.0)	-9.9 (22.8)	0.8 (7.1)	1.0 (10.5)

13. Primary Outcome

Title	The Change From Baseline in Vital Signs: Diastolic Blood Pressure
Time Frame	Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
3 hours post Hemodialysis	-3.7 (10.5)	0.2 (10.9)	0.1 (9.0)	0.5 (9.3)
24 hours post dose	-2.8 (9.9)	-2.2 (8.7)	NA (NA)	NA (NA)

14. Primary Outcome

Title	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
Time Frame	Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatments: A = UFH intravenous infusion
Measure Participants	32	31	31	32
3 hours post hemodialysis	-6.6 (28.2)	1.1 (24.9)	-0.2 (17.0)	-5.8 (18.0)
24 hours post dose	-8.4 (23.7)	-9.2 (17.6)	NA (NA)	NA (NA)

15. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Cmax
Description	Cmax: Maximum observed plasma concentration
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [ng/mL]	1120 (391.8)	3342 (922.2)

16. Primary Outcome

Title	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
Time Frame	Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Treatment B	Treatment C	Treatment D	Treatment A
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension	Treatment D = enoxaparin 40 mg by subcutaneous injection	Treatment A = UFH intravenous infusion
Measure Participants	32	31	31	32
3 hours post hemodialysis	4.9 (9.4)	4.0 (7.4)	4.5 (6.5)	3.3 (8.9)
24 hours post dose	4.2 (5.6)	1.1 (7.0)	NA (NA)	NA (NA)

17. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Tmax
Description	Time of maximum observed plasma concentration
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [h]	4.531 (0.933)	4.855 (1.042)

18. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)
Description	AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
AUC (0-T)	10406.6 (4551.7)	36112.9 (19802.5)
AUC (0-24)	10533.4 (4492.8)	34028.0 (12191.9)

19. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: fu
Description	Fraction of unbound drug
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [Percentage]	7.644 (1.257)	7.868 (1.481)

20. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Cmaxfu
Description	Maximum observed plasma concentration of free drug
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [ng/mL]	84.32 (30.14)	257.9 (70.40)

21. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
Description	AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [ng.h/mL]	783.5 (342.1)	2782.2 (1537.7)

22. Secondary Outcome

Title	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
Description	AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis. Determined from blood samples entering and exiting the dialyzer)
Time Frame	Either Day 1, 5, 8, or 12 depending on the randomization sequence

Outcome Measure Data

Analysis Population Description

All treated and evaluable participants

Arm/Group Title	Treatment B	Treatment C
Arm/Group Description	Treatment B = BMS-986177 100 mg oral suspension	Treatment C = BMS-986177 300 mg oral suspension
Measure Participants	32	31
Mean (Standard Deviation) [ng.h/mL]	2847.4 (1039.1)	8558.1 (2509.1)

Adverse Events

Time Frame	From the date of the patient's written consent to participate in the study until 30 days after discontinuation of dosing
Adverse Event Reporting Description	The collection of nonserious AE information began 3 hours prior to dialysis start on Day 1, and continued until the follow-up contact
Arm/Group Title	Treatment A		Treatment B		Treatment C		Treatment D
Arm/Group Description	Treatment A = UFH intravenous infusion;		Treatment B = BMS-986177 100 mg		Treatment C = BMS-986177 300 mg		Treatment D = enoxaparin 40 mg by subcutaneous injection
All Cause Mortality
	Treatment A		Treatment B		Treatment C		Treatment D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)		0/31 (0%)		0/31 (0%)
Serious Adverse Events
	Treatment A		Treatment B		Treatment C		Treatment D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)		0/31 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A		Treatment B		Treatment C		Treatment D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)		0/31 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.