A Study to Evaluate Safety of Single Doses of BMS-986177... | NCT03000673

NCT03000673

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Sequence 1	Active Comparator	UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin	Drug: Enoxaparin Drug: unfractionated heparin (UFH) Drug: BMS-986177
Dose Sequence 2	Active Comparator	BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2	Drug: Enoxaparin Drug: unfractionated heparin (UFH) Drug: BMS-986177
Dose Sequence 3	Active Comparator	BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1	Drug: Enoxaparin Drug: unfractionated heparin (UFH) Drug: BMS-986177
Dose Sequence 4	Active Comparator	Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH	Drug: Enoxaparin Drug: unfractionated heparin (UFH) Drug: BMS-986177

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin	Drug	Specified dose of Enoxaparin on specified days	Dose Sequence 1 Dose Sequence 2 Dose Sequence 3 Dose Sequence 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	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	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)
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85PRE-RX; HEMATOCRIT HCT % LOW < 0.85PRE-RX; PLATELET COUNT PLAT X109 C/L LOW < 0.85LLN IF PRE-RX IS MISSING; < 0.85LLN IF PRE-RX >= LLN; < 0.85PRE-RX IF PRE-RX < LLN; HIGH > 1.5ULN; HEMATOLOGY II; LEUKOCYTES WBC X103 C/UL LOW < 0.9LLN IF PRE-RX IS MISSING; < 0.9LLN IF LLN <= PRE-RX <= ULN; < 0.85PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.2ULN IF PRE-RX IS MISSING; > 1.2ULN IF LLN <= PRE-RX <= ULN; > 1.5PRE-RX IF PRE-RX > ULN; NEUTROPHILS (ABSOLUTE) NEUTA X103 C/UL LOW < 1.5 IF PRE-RX IS MISSING; < 1.5 IF PRE-RX >= 1.5; < 0.85PRE-RX IF; PRE-RX < 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X103 C/UL LOW < 0.75; HIGH > 7.5; MONOCYTES (ABSOLUTE) MONOA X103 C/UL HIGH > 2; BASOPHILS (ABSOLUTE) BASOA X103 C/UL HIGH > 0.4; EOSINOPHILS (ABSOLUTE) EOSA X103 C/UL HIGH > 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH > 1.5ULN; APTT APTT SEC HIGH > 1.5ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH > 1.5*ULN;	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.
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	LIVER & KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25ULN IF PRE-RX IS MISSING; > 1.25ULN IF PRE-RX <= ULN; > 1.25PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH > 1.25ULN IF PRE-RX IS MISSING; > 1.25ULN IF PRE-RX <= ULN; > 1.25PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH > 1.25ULN IF PRE-RX IS MISSING; > 1.25ULN IF PRE-RX <= ULN; > 1.25PRE-RX IF PRE-RX > ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH > 1.1ULN IF PRE-RX IS MISSING; > 1.1ULN IF PRE-RX <= ULN; > 1.25PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH > 1.1ULN IF PRE-RX IS MISSING; > 1.1ULN IF PRE-RX <= ULN; > 1.25PRE-RX IF PRE-RX > ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH > 1.1ULN IF PRE-RX IS MISSING; > 1.1ULN IF PRE-RX <= ULN; > 1.2PRE-RX IF PRE-RX > ULN; CREATININE CREAT MG/DL HIGH > 1.5ULN IF PRE-RX IS MISSING; > 1.5ULN IF PRE-RX <= ULN; > 1.33*PRE-RX IF PRE-RX > ULN;

Secondary Outcomes

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

Eligibility Module

Eligibility 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

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Davita Clinical Research		Lakewood	Colorado	80228	United States
Orlando Clinical Research Center

References Module

Label	URL
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequence ABCD	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
FG001	Sequence BDAC	Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 6, 2017	Oct 30, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Time of maximum observed plasma concentration

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Seq ABCD	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
BG001	Seq BDAC	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
BG002	Seq CADB	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
BG003	Seq DCBA	Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG0019 BG0027 BG0039 BG00432

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00055.1± 7.3 BG00155.6± 6.6 BG00252.0± 12.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0015 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG0001 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death

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

All treated participants

Posted

Number

Participants

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)

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts
Participants	OG00032 OG00131 OG00231 OG003

Title

Denominators

Categories

Adverse Events

Title	Measurements
	OG0004 OG0014 OG0023 OG003

Primary

The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation

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;

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C

Primary

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function

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;

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Primary

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes

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;

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002

Primary

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)

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

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002

Primary

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing

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

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C

Primary

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies

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

All treated participants with evaluable test results

Posted

Count of Participants

Participants

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.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Primary

The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate

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

All treated participants

Posted

Mean

Standard Deviation

Beats/min

Days -3 to -1, Days 1, 5, 8, and 12.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts

Primary

The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate

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

All treated participants

Posted

Mean

Standard Deviation

msec

Days -3 to -1, Days 1, 5, 8, and 12.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts

Primary

The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate

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

All treated participants

Posted

Mean

Standard Deviation

msec

Days -3 to -1, Days 1, 5, 8, and 12.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts

Primary

The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate

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

All treated participants

Posted

Mean

Standard Deviation

msec

Days -3 to -1, Days 1, 5, 8, and 12.

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts

Primary

The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate

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.

All treated participants

Posted

Mean

Standard Deviation

msec

Days -3 to -1, Days 1, 5, 8, and 12

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units

Primary

The Change From Baseline in Vital Signs: Diastolic Blood Pressure

All treated participants

Posted

Mean

Standard Deviation

mmHg

Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts
Participants

Primary

The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)

All treated participants

Posted

Mean

Standard Deviation

mmHg

Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatments: A = UFH intravenous infusion

Units	Counts
Participants

Secondary

Pharmacokinetic Parameters of BMS-986177: Cmax

Cmax: Maximum observed plasma concentration

All treated and evaluable participants

Posted

Mean

Standard Deviation

ng/mL

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Primary

The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)

All treated participants

Posted

Mean

Standard Deviation

beats/min

Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension
OG002	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection
OG003	Treatment A	Treatment A = UFH intravenous infusion

Units	Counts
Participants

Secondary

Pharmacokinetic Parameters of BMS-986177: Tmax

Time of maximum observed plasma concentration

All treated and evaluable participants

Posted

Mean

Standard Deviation

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)

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

All treated and evaluable participants

Posted

Mean

Standard Deviation

ng.h/mL

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters of BMS-986177: fu

Fraction of unbound drug

All treated and evaluable participants

Posted

Mean

Standard Deviation

Percentage

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters of BMS-986177: Cmaxfu

Maximum observed plasma concentration of free drug

All treated and evaluable participants

Posted

Mean

Standard Deviation

ng/mL

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu

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

All treated and evaluable participants

Posted

Mean

Standard Deviation

ng.h/mL

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Secondary

Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)

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)

All treated and evaluable participants

Posted

Mean

Standard Deviation

ng.h/mL

Either Day 1, 5, 8, or 12 depending on the randomization sequence

ID	Title	Description
OG000	Treatment B	Treatment B = BMS-986177 100 mg oral suspension
OG001	Treatment C	Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Treatment A	Treatment A = UFH intravenous infusion;	32	32	32
EG001	Treatment B	Treatment B = BMS-986177 100 mg	32	32	32
EG002	Treatment C	Treatment C = BMS-986177 300 mg	31	31	31
EG003	Treatment D	Treatment D = enoxaparin 40 mg by subcutaneous injection	31	31	31

First MCP Posted Date

ID	Term
D017984	Enoxaparin
D006493	Heparin
C000720754	milvexian

Treatment C = BMS-986177 300 mg oral suspension

Units	Counts
Participants	OG00032 OG00131 OG00231 OG00332

Title	Measurements
	OG0003 OG0014 OG0022 OG0032

Title	Measurements
	OG0004 OG00125 OG0021 OG0030

Title	Measurements
	OG0001 OG0010 OG0020 OG0031

Title	Measurements
	OG0000 OG0010 OG0020 OG0030

Title	Measurements
	OG0000 OG0010 OG0021 OG0030

Title	Measurements
	OG0000 OG0010 OG0021 OG0030

Title	Measurements
	OG0000 OG0010 OG0021 OG0032

Title	Measurements
	OG0000 OG0010 OG0023 OG0030

Title	Measurements
	OG0000 OG0010 OG0021 OG0030

Title	Measurements
	OG000-2.1± 6.9 OG0012.0± 10.8 OG0022.0± 8.1 OG0031.6± 5.9

Title	Measurements
	OG0000.0± 6.9 OG001-2.8± 6.1 OG0022.3± 4.7 OG0034.0± 9.8

Title	Measurements
	OG0000.4± 6.0 OG0013.9± 9.5 OG0020.8± 2.9 OG0031.4± 9.5

Title	Measurements
	OG00012.6± 21.2 OG001-5.8± 8.9 OG002-5.1± 11.8 OG003-25.4± 66.5

Title	Measurements
	OG000-1.2± 19.3 OG00112.7± 25.5 OG002-22.6± 70.3 OG003-3.4± 27.2

Title	Measurements
	OG000-27.7± 67.9 OG001-5.6± 8.7 OG0028.8± 12.4 OG003-2.6± 8.7

Title	Measurements
	OG000-0.3± 14.8 OG001-0.2± 4.6 OG002-0.2± 4.6 OG0030.6± 4.8

Title	Measurements
	OG000-0.2± 4.2 OG001-1.8± 8.8 OG002-0.7± 6.0 OG0030.3± 8.6

Title	Measurements
	OG0000.9± 6.3 OG001-0.1± 9.3 OG002-0.7± 9.7 OG0032.0± 7.0

Title	Measurements
	OG0008.4± 19.3 OG001-7.4± 20.1 OG002-2.8± 22.0 OG0035.6± 15.9

Title	Measurements
	OG000-1.8± 21.3 OG00112.0± 11.9 OG002-3.6± 24.0 OG003-7.4± 26.8

Title	Measurements
	OG0000.7± 20.1 OG001-14.9± 28.2 OG002-0.7± 10.8 OG003-2.2± 20.4

Title	Measurements
	OG0005.1± 7.6 OG001-4.9± 11.8 OG002-0.6± 13.1 OG0039.9± 14.7

Title	Measurements
	OG000-1.3± 17.1 OG0016.2± 6.7 OG0020.3± 19.7 OG003-2.1± 18.5

Title	Measurements
	OG0002.1± 15.0 OG001-9.9± 22.8 OG0020.8± 7.1 OG0031.0± 10.5

Title	Measurements
	OG000-2.8± 9.9 OG001-2.2± 8.7 OG002NA± NANo dose of BMS-986177, as Treatment D was Enoxaparin 40 mg by subcutaneous injection OG003NA± NANo dose of BMS-986177, as Treatment A was UFH intravenous infusion

Title	Measurements
	OG000-8.4± 23.7 OG001-9.2± 17.6 OG002NA± NANo dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection OG003NA± NANo dose of BMS-986177, as Treatment A was UFH intravenous infusion

Title	Measurements
	OG0004.2± 5.6 OG0011.1± 7.0 OG002NA± NANo dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection OG003NA± NANo dose of BMS-986177, as Treatment A was UFH intravenous infusion

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates