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

A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03000673

Enrollment

Registered

2016-12-22

Start date

2017-05-23

Completion date

2017-10-23

Last updated

2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antithrombotic

Brief summary

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

Interventions

DRUGEnoxaparin

Specified dose of Enoxaparin on specified days

DRUGunfractionated heparin (UFH)

Specified dose of UFH on specified days

DRUGBMS-986177

Specified dose of BMS-986177 on specified day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame	Description
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	—
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.
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.
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.
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.
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.
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	—
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	—
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
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;
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;
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;
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
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
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

Secondary

Measure	Time frame	Description
Pharmacokinetic Parameters of BMS-986177: Tmax	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Time of maximum observed plasma concentration
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
Pharmacokinetic Parameters of BMS-986177: fu	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Fraction of unbound drug
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
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
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)
Pharmacokinetic Parameters of BMS-986177: Cmax	Either Day 1, 5, 8, or 12 depending on the randomization sequence	Cmax: Maximum observed plasma concentration

Countries

United States

Participant flow

Pre-assignment details

32 participants were randomized and treated.

Participants by arm

Arm	Count
Seq ABCD Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection	7
Seq BDAC Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.	9
Seq CADB Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection	7
Seq DCBA Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.	9
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Withdrawal by Subject	1	0	0	0

Baseline characteristics

Characteristic	Total	Seq ABCD	Seq BDAC	Seq CADB	Seq DCBA
Age, Continuous	53.6 Years STANDARD_DEVIATION 8.9	55.1 Years STANDARD_DEVIATION 7.3	55.6 Years STANDARD_DEVIATION 6.6	52.0 Years STANDARD_DEVIATION 12.4	51.7 Years STANDARD_DEVIATION 9.9
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants	7 Participants	9 Participants	7 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Black or African American	29 Participants	6 Participants	9 Participants	6 Participants	8 Participants
Race/Ethnicity, Customized White	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Sex: Female, Male Female	12 Participants	1 Participants	5 Participants	3 Participants	3 Participants
Sex: Female, Male Male	20 Participants	6 Participants	4 Participants	4 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 32	0 / 32	0 / 31	0 / 31
other Total, other adverse events	0 / 32	0 / 32	0 / 31	0 / 31
serious Total, serious adverse events	0 / 32	0 / 32	0 / 31	0 / 31

Outcome results

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.

Time frame: Days -3 to -1, Days 1, 5, 8, and 12.

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 1	1.8 Beats/min	Standard Deviation 8.6
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 5	-2.1 Beats/min	Standard Deviation 6.9
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 8	0.0 Beats/min	Standard Deviation 6.9
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 12	0.4 Beats/min	Standard Deviation 6
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 5	2.0 Beats/min	Standard Deviation 10.8
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 8	-2.8 Beats/min	Standard Deviation 6.1
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 12	3.9 Beats/min	Standard Deviation 9.5
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 1	1.4 Beats/min	Standard Deviation 5.1
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 8	2.3 Beats/min	Standard Deviation 4.7
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 5	2.0 Beats/min	Standard Deviation 8.1
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 12	0.8 Beats/min	Standard Deviation 2.9
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 1	0.4 Beats/min	Standard Deviation 8.1
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 12	1.4 Beats/min	Standard Deviation 9.5
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 5	1.6 Beats/min	Standard Deviation 5.9
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 1	-0.1 Beats/min	Standard Deviation 5.4
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate	Day 8	4.0 Beats/min	Standard Deviation 9.8

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.

Time frame: Days -3 to -1, Days 1, 5, 8, and 12.

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 1	-1.3 msec	Standard Deviation 9.9
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 5	12.6 msec	Standard Deviation 21.2
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 8	-1.2 msec	Standard Deviation 19.3
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 12	-27.7 msec	Standard Deviation 67.9
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 5	-5.8 msec	Standard Deviation 8.9
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 8	12.7 msec	Standard Deviation 25.5
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 12	-5.6 msec	Standard Deviation 8.7
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 1	-25.0 msec	Standard Deviation 67.8
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 8	-22.6 msec	Standard Deviation 70.3
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 5	-5.1 msec	Standard Deviation 11.8
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 12	8.8 msec	Standard Deviation 12.4
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 1	-6.9 msec	Standard Deviation 12.6
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 12	-2.6 msec	Standard Deviation 8.7
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 5	-25.4 msec	Standard Deviation 66.5
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 1	13.6 msec	Standard Deviation 26.3
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate	Day 8	-3.4 msec	Standard Deviation 27.2

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.

Time frame: Days -3 to -1, Days 1, 5, 8, and 12.

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 1	-1.1 msec	Standard Deviation 6.7
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 5	-0.3 msec	Standard Deviation 14.8
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 8	-0.2 msec	Standard Deviation 4.2
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 12	0.9 msec	Standard Deviation 6.3
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 5	-0.2 msec	Standard Deviation 4.6
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 8	-1.8 msec	Standard Deviation 8.8
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 12	-0.1 msec	Standard Deviation 9.3
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 1	5.7 msec	Standard Deviation 6.2
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 8	-0.7 msec	Standard Deviation 6
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 5	-0.2 msec	Standard Deviation 4.6
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 12	-0.7 msec	Standard Deviation 9.7
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 1	-0.2 msec	Standard Deviation 3.3
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 12	2.0 msec	Standard Deviation 7
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 5	0.6 msec	Standard Deviation 4.8
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 1	-3.1 msec	Standard Deviation 11
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate	Day 8	0.3 msec	Standard Deviation 8.6

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.

Time frame: Days -3 to -1, Days 1, 5, 8, and 12

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 1	-3.2 msec	Standard Deviation 15.3
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 5	5.1 msec	Standard Deviation 7.6
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 8	-1.3 msec	Standard Deviation 17.1
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 12	2.1 msec	Standard Deviation 15
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 5	-4.9 msec	Standard Deviation 11.8
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 8	6.2 msec	Standard Deviation 6.7
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 12	-9.9 msec	Standard Deviation 22.8
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 1	1.7 msec	Standard Deviation 13.5
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 8	0.3 msec	Standard Deviation 19.7
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 5	-0.6 msec	Standard Deviation 13.1
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 12	0.8 msec	Standard Deviation 7.1
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 1	-1.0 msec	Standard Deviation 16.5
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 12	1.0 msec	Standard Deviation 10.5
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 5	9.9 msec	Standard Deviation 14.7
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 1	5.7 msec	Standard Deviation 15.7
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate	Day 8	-2.1 msec	Standard Deviation 18.5

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.

Time frame: Days -3 to -1, Days 1, 5, 8, and 12.

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 1	-3.7 msec	Standard Deviation 22.2
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 5	8.4 msec	Standard Deviation 19.3
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 8	-1.8 msec	Standard Deviation 21.3
Treatment B	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 12	0.7 msec	Standard Deviation 20.1
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 5	-7.4 msec	Standard Deviation 20.1
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 8	12.0 msec	Standard Deviation 11.9
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 12	-14.9 msec	Standard Deviation 28.2
Treatment C	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 1	-1.6 msec	Standard Deviation 20.8
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 8	-3.6 msec	Standard Deviation 24
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 5	-2.8 msec	Standard Deviation 22
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 12	-0.7 msec	Standard Deviation 10.8
Treatment D	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 1	-3.1 msec	Standard Deviation 24
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 12	-2.2 msec	Standard Deviation 20.4
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 5	5.6 msec	Standard Deviation 15.9
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 1	3.9 msec	Standard Deviation 23.2
Treatment A	The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate	Day 8	-7.4 msec	Standard Deviation 26.8

Primary

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

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	3 hours post Hemodialysis	-3.7 mmHg	Standard Deviation 10.5
Treatment B	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	24 hours post dose	-2.8 mmHg	Standard Deviation 9.9
Treatment C	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	24 hours post dose	-2.2 mmHg	Standard Deviation 8.7
Treatment C	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	3 hours post Hemodialysis	0.2 mmHg	Standard Deviation 10.9
Treatment D	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	3 hours post Hemodialysis	0.1 mmHg	Standard Deviation 9
Treatment D	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	24 hours post dose	NA mmHg	—
Treatment A	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	3 hours post Hemodialysis	0.5 mmHg	Standard Deviation 9.3
Treatment A	The Change From Baseline in Vital Signs: Diastolic Blood Pressure	24 hours post dose	NA mmHg	—

Primary

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

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	3 hours post hemodialysis	4.9 beats/min	Standard Deviation 9.4
Treatment B	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	24 hours post dose	4.2 beats/min	Standard Deviation 5.6
Treatment C	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	24 hours post dose	1.1 beats/min	Standard Deviation 7
Treatment C	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	3 hours post hemodialysis	4.0 beats/min	Standard Deviation 7.4
Treatment D	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	3 hours post hemodialysis	4.5 beats/min	Standard Deviation 6.5
Treatment D	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	24 hours post dose	NA beats/min	—
Treatment A	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	3 hours post hemodialysis	3.3 beats/min	Standard Deviation 8.9
Treatment A	The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)	24 hours post dose	NA beats/min	—

Primary

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

Population: All treated participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	3 hours post hemodialysis	-6.6 mmHg	Standard Deviation 28.2
Treatment B	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	24 hours post dose	-8.4 mmHg	Standard Deviation 23.7
Treatment C	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	24 hours post dose	-9.2 mmHg	Standard Deviation 17.6
Treatment C	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	3 hours post hemodialysis	1.1 mmHg	Standard Deviation 24.9
Treatment D	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	3 hours post hemodialysis	-0.2 mmHg	Standard Deviation 17
Treatment D	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	24 hours post dose	NA mmHg	—
Treatment A	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	3 hours post hemodialysis	-5.8 mmHg	Standard Deviation 18
Treatment A	The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)	24 hours post dose	NA mmHg	—

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

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)

Population: All treated participants

Arm	Measure	Group	Value (NUMBER)
Treatment B	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events	4 Participants
Treatment B	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Serious Adverse Events	0 Participants
Treatment B	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events Leading to Discontinuations	0 Participants
Treatment B	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Deaths	0 Participants
Treatment C	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Serious Adverse Events	0 Participants
Treatment C	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events Leading to Discontinuations	0 Participants
Treatment C	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Deaths	0 Participants
Treatment C	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events	4 Participants
Treatment D	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events Leading to Discontinuations	0 Participants
Treatment D	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Serious Adverse Events	0 Participants
Treatment D	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Deaths	0 Participants
Treatment D	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events	3 Participants
Treatment A	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Deaths	0 Participants
Treatment A	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Serious Adverse Events	0 Participants
Treatment A	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events	2 Participants
Treatment A	The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death	Adverse Events Leading to Discontinuations	0 Participants

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;

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

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Not reported	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal high	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Not reported	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Not reported	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Sodium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal high	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Not reported	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Potassium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes	Chloride, Serum (MEQ/L) Abnormal low	0 Participants

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

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.

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Not reported	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal low	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal low	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal low	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal low	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Not reported	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal low	2 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Calcium, Total (MG/DL) Abnormal low	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Magnesium, Serum (MEQ/L), Abnormal low	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)	Phosphorus, Inorganic (MG/DL) Abnormal high	0 Participants

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;

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.

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALP (U/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Not reported	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALT (U/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Total (MG/DL) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL) Abnormal high	1 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL), Not reported	1 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Blood Urea Nitrogen (MG/DL) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Not reported	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALT (U/L) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Total (MG/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL) Abnormal high	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL), Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Blood Urea Nitrogen (MG/DL) Abnormal high	1 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALP (U/L) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Blood Urea Nitrogen (MG/DL) Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL), Not reported	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Not reported	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALP (U/L) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALT (U/L) Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL) Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Total (MG/DL) Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Not reported	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Total (MG/DL) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Blood Urea Nitrogen (MG/DL) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL) Abnormal high	3 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Not reported	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Bilirubin, Direct (MG/DL), Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	AST (U/L) Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALT (U/L) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	ALP (U/L) Abnormal high	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function	Creatinine (MG/DL) Abnormal high	0 Participants

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

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.

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal high	2 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Albumin (G/DL) Abnormal low	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Not reported	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Uric Acid (MG/DL) Abnormal High	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Abnormal high	0 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Albumin (G/DL) Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Not reported	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Uric Acid (MG/DL) Abnormal High	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal low	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal high	2 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Uric Acid (MG/DL) Abnormal High	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Not reported	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Not reported	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal low	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Abnormal high	3 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal high	4 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Albumin (G/DL) Abnormal low	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal low	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Albumin (G/DL) Abnormal low	2 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Uric Acid (MG/DL) Abnormal High	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Creatine Kinase (CK) (U/L) Not reported	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal high	4 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal low	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Protein, Total (G/DL) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	Glucose, Fasting serum (MG/DL) Abnormal low	1 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing	LD (U/L) Abnormal high	0 Participants

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

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.

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Blood, Urine (N/A) Abnormal high	1 Participants
Treatment B	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Occult Blood Screen, Feces (N/A) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Occult Blood Screen, Feces (N/A) Abnormal high	0 Participants
Treatment C	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Blood, Urine (N/A) Abnormal high	1 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Blood, Urine (N/A) Abnormal high	0 Participants
Treatment D	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Occult Blood Screen, Feces (N/A) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Blood, Urine (N/A) Abnormal high	0 Participants
Treatment A	The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies	Occult Blood Screen, Feces (N/A) Abnormal high	0 Participants

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;

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.

Population: All treated participants with evaluable test results

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Basophils (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL): Abnormal high	0 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	INR (fraction): Abnormal high	0 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	3 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Neutrophils (Absolute) (X10*3 C/UL)	0 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Abnormal high	4 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematology I Hemoglobin (G/DL) Abnormal low	3 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Platelet Count (X10*9 C/L) Abnormal low	1 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Not reported	1 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Prothrombin time (PT) (sec): Abnormal high	1 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Eosinophils (Absolute) (X10*3 C/UL)	1 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL) Abnormal low	2 Participants
Treatment B	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematocrit (%) Abnormal low	3 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Prothrombin time (PT) (sec): Abnormal high	1 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematology I Hemoglobin (G/DL) Abnormal low	3 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematocrit (%) Abnormal low	4 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Platelet Count (X10*9 C/L) Abnormal low	1 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL) Abnormal low	1 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL): Abnormal high	0 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Neutrophils (Absolute) (X10*3 C/UL)	0 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	4 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Basophils (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Eosinophils (Absolute) (X10*3 C/UL)	1 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Abnormal high	25 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Not reported	0 Participants
Treatment C	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	INR (fraction): Abnormal high	0 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Prothrombin time (PT) (sec): Abnormal high	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Not reported	0 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematocrit (%) Abnormal low	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL) Abnormal low	0 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Abnormal high	1 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematology I Hemoglobin (G/DL) Abnormal low	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Eosinophils (Absolute) (X10*3 C/UL)	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Neutrophils (Absolute) (X10*3 C/UL)	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Platelet Count (X10*9 C/L) Abnormal low	2 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL): Abnormal high	1 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	INR (fraction): Abnormal high	0 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	3 Participants
Treatment D	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Basophils (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	5 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Not reported	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Basophils (Absolute) (X10*3 C/UL) Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Platelet Count (X10*9 C/L) Abnormal low	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Eosinophils (Absolute) (X10*3 C/UL)	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematocrit (%) Abnormal low	2 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Prothrombin time (PT) (sec): Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	INR (fraction): Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	APTT (sec): Abnormal high	0 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL): Abnormal high	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Hematology I Hemoglobin (G/DL) Abnormal low	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Neutrophils (Absolute) (X10*3 C/UL)	1 Participants
Treatment A	The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation	Leukocytes (X10*3 C/UL) Abnormal low	2 Participants

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

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

Population: All treated and evaluable participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)	AUC (0-T)	10406.6 ng.h/mL	Standard Deviation 4551.7
Treatment B	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)	AUC (0-24)	10533.4 ng.h/mL	Standard Deviation 4492.8
Treatment C	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)	AUC (0-T)	36112.9 ng.h/mL	Standard Deviation 19802.5
Treatment C	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)	AUC (0-24)	34028.0 ng.h/mL	Standard Deviation 12191.9

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

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu	783.5 ng.h/mL	Standard Deviation 342.1
Treatment C	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu	2782.2 ng.h/mL	Standard Deviation 1537.7

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)

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)	2847.4 ng.h/mL	Standard Deviation 1039.1
Treatment C	Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)	8558.1 ng.h/mL	Standard Deviation 2509.1

Secondary

Pharmacokinetic Parameters of BMS-986177: Cmax

Cmax: Maximum observed plasma concentration

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Cmax	1120 ng/mL	Standard Deviation 391.8
Treatment C	Pharmacokinetic Parameters of BMS-986177: Cmax	3342 ng/mL	Standard Deviation 922.2

Secondary

Pharmacokinetic Parameters of BMS-986177: Cmaxfu

Maximum observed plasma concentration of free drug

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Cmaxfu	84.32 ng/mL	Standard Deviation 30.14
Treatment C	Pharmacokinetic Parameters of BMS-986177: Cmaxfu	257.9 ng/mL	Standard Deviation 70.4

Secondary

Pharmacokinetic Parameters of BMS-986177: fu

Fraction of unbound drug

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: fu	7.644 Percentage	Standard Deviation 1.257
Treatment C	Pharmacokinetic Parameters of BMS-986177: fu	7.868 Percentage	Standard Deviation 1.481

Secondary

Pharmacokinetic Parameters of BMS-986177: Tmax

Time of maximum observed plasma concentration

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

Population: All treated and evaluable participants

Arm	Measure	Value (MEAN)	Dispersion
Treatment B	Pharmacokinetic Parameters of BMS-986177: Tmax	4.531 h	Standard Deviation 0.933
Treatment C	Pharmacokinetic Parameters of BMS-986177: Tmax	4.855 h	Standard Deviation 1.042

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

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

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

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

The Change From Baseline in Vital Signs: Diastolic Blood Pressure

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

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

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

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

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

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

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

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

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

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

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

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

Pharmacokinetic Parameters of BMS-986177: Cmax

Pharmacokinetic Parameters of BMS-986177: Cmaxfu

Pharmacokinetic Parameters of BMS-986177: fu

Pharmacokinetic Parameters of BMS-986177: Tmax