Trial Outcomes & Findings for A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis (NCT NCT03000673)
NCT ID: NCT03000673
Last Updated: 2020-12-29
Results Overview
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
COMPLETED
PHASE1/PHASE2
32 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)
2020-12-29
Participant Flow
32 participants were randomized and treated.
Participant milestones
| Measure |
Sequence ABCD
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence BDAC
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence CADB
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence DCBA
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence ABCD
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence BDAC
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence CADB
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
Sequence DCBA
Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
Baseline characteristics by cohort
| Measure |
Seq ABCD
n=7 Participants
Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
|
Seq BDAC
n=9 Participants
Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
|
Seq CADB
n=7 Participants
Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection
|
Seq DCBA
n=9 Participants
Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.1 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
55.6 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
52.0 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
51.7 Years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
53.6 Years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Adverse Events
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Adverse Events Leading to Discontinuations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
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;
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
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
|
4 Participants
|
3 Participants
|
5 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Eosinophils (Absolute) (X10*3 C/UL)
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Prothrombin time (PT) (sec): Abnormal high
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
APTT (sec): Abnormal high
|
4 Participants
|
25 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
APTT (sec): Not reported
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
INR (fraction): Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Hematology I Hemoglobin (G/DL) Abnormal low
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Hematocrit (%) Abnormal low
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
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
|
1 Participants
|
2 Participants
|
1 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Leukocytes (X10*3 C/UL) Abnormal low
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Leukocytes (X10*3 C/UL): Abnormal high
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
Neutrophils (Absolute) (X10*3 C/UL)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 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
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;
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
ALP (U/L) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
AST (U/L) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
AST (U/L) Not reported
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
ALT (U/L) Abnormal high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Bilirubin, Total (MG/DL) Abnormal high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Bilirubin, Direct (MG/DL) Abnormal high
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Bilirubin, Direct (MG/DL), Not reported
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Blood Urea Nitrogen (MG/DL) Abnormal high
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Creatinine (MG/DL) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
Creatinine (MG/DL) Not reported
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study dischargePopulation: All treated participants with evaluable test results
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;
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Sodium, Serum (MEQ/L), Abnormal low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Sodium, Serum (MEQ/L), Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Potassium, Serum (MEQ/L), Abnormal low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Potassium, Serum (MEQ/L), Abnormal high
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Potassium, Serum (MEQ/L), Not reported
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Chloride, Serum (MEQ/L) Abnormal low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Chloride, Serum (MEQ/L) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
Chloride, Serum (MEQ/L) Not reported
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Magnesium, Serum (MEQ/L), Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Calcium, Total (MG/DL) Abnormal low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Calcium, Total (MG/DL) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Phosphorus, Inorganic (MG/DL) Abnormal low
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Phosphorus, Inorganic (MG/DL) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Magnesium, Serum (MEQ/L), Abnormal low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
Magnesium, Serum (MEQ/L), Not reported
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Glucose, Fasting serum (MG/DL) Abnormal low
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Glucose, Fasting serum (MG/DL) Abnormal high
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Protein, Total (G/DL) Abnormal low
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Protein, Total (G/DL) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Albumin (G/DL) Abnormal low
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Creatine Kinase (CK) (U/L) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Creatine Kinase (CK) (U/L) Not reported
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
Uric Acid (MG/DL) Abnormal High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
LD (U/L) Abnormal high
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
LD (U/L) Not reported
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
Blood, Urine (N/A) Abnormal high
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
Occult Blood Screen, Feces (N/A) Abnormal high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.Population: All treated participants
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Day 1
|
1.8 Beats/min
Standard Deviation 8.6
|
1.4 Beats/min
Standard Deviation 5.1
|
0.4 Beats/min
Standard Deviation 8.1
|
-0.1 Beats/min
Standard Deviation 5.4
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Day 5
|
-2.1 Beats/min
Standard Deviation 6.9
|
2.0 Beats/min
Standard Deviation 10.8
|
2.0 Beats/min
Standard Deviation 8.1
|
1.6 Beats/min
Standard Deviation 5.9
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Day 8
|
0.0 Beats/min
Standard Deviation 6.9
|
-2.8 Beats/min
Standard Deviation 6.1
|
2.3 Beats/min
Standard Deviation 4.7
|
4.0 Beats/min
Standard Deviation 9.8
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Day 12
|
0.4 Beats/min
Standard Deviation 6.0
|
3.9 Beats/min
Standard Deviation 9.5
|
0.8 Beats/min
Standard Deviation 2.9
|
1.4 Beats/min
Standard Deviation 9.5
|
PRIMARY outcome
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.Population: All treated participants
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Day 1
|
-1.3 msec
Standard Deviation 9.9
|
-25.0 msec
Standard Deviation 67.8
|
-6.9 msec
Standard Deviation 12.6
|
13.6 msec
Standard Deviation 26.3
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Day 5
|
12.6 msec
Standard Deviation 21.2
|
-5.8 msec
Standard Deviation 8.9
|
-5.1 msec
Standard Deviation 11.8
|
-25.4 msec
Standard Deviation 66.5
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Day 8
|
-1.2 msec
Standard Deviation 19.3
|
12.7 msec
Standard Deviation 25.5
|
-22.6 msec
Standard Deviation 70.3
|
-3.4 msec
Standard Deviation 27.2
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Day 12
|
-27.7 msec
Standard Deviation 67.9
|
-5.6 msec
Standard Deviation 8.7
|
8.8 msec
Standard Deviation 12.4
|
-2.6 msec
Standard Deviation 8.7
|
PRIMARY outcome
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.Population: All treated participants
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Day 1
|
-1.1 msec
Standard Deviation 6.7
|
5.7 msec
Standard Deviation 6.2
|
-0.2 msec
Standard Deviation 3.3
|
-3.1 msec
Standard Deviation 11.0
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Day 5
|
-0.3 msec
Standard Deviation 14.8
|
-0.2 msec
Standard Deviation 4.6
|
-0.2 msec
Standard Deviation 4.6
|
0.6 msec
Standard Deviation 4.8
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Day 8
|
-0.2 msec
Standard Deviation 4.2
|
-1.8 msec
Standard Deviation 8.8
|
-0.7 msec
Standard Deviation 6.0
|
0.3 msec
Standard Deviation 8.6
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Day 12
|
0.9 msec
Standard Deviation 6.3
|
-0.1 msec
Standard Deviation 9.3
|
-0.7 msec
Standard Deviation 9.7
|
2.0 msec
Standard Deviation 7.0
|
PRIMARY outcome
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.Population: All treated participants
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Day 1
|
-3.7 msec
Standard Deviation 22.2
|
-1.6 msec
Standard Deviation 20.8
|
-3.1 msec
Standard Deviation 24.0
|
3.9 msec
Standard Deviation 23.2
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Day 5
|
8.4 msec
Standard Deviation 19.3
|
-7.4 msec
Standard Deviation 20.1
|
-2.8 msec
Standard Deviation 22.0
|
5.6 msec
Standard Deviation 15.9
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Day 8
|
-1.8 msec
Standard Deviation 21.3
|
12.0 msec
Standard Deviation 11.9
|
-3.6 msec
Standard Deviation 24.0
|
-7.4 msec
Standard Deviation 26.8
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Day 12
|
0.7 msec
Standard Deviation 20.1
|
-14.9 msec
Standard Deviation 28.2
|
-0.7 msec
Standard Deviation 10.8
|
-2.2 msec
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12Population: All treated participants
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.
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Day 1
|
-3.2 msec
Standard Deviation 15.3
|
1.7 msec
Standard Deviation 13.5
|
-1.0 msec
Standard Deviation 16.5
|
5.7 msec
Standard Deviation 15.7
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Day 5
|
5.1 msec
Standard Deviation 7.6
|
-4.9 msec
Standard Deviation 11.8
|
-0.6 msec
Standard Deviation 13.1
|
9.9 msec
Standard Deviation 14.7
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Day 8
|
-1.3 msec
Standard Deviation 17.1
|
6.2 msec
Standard Deviation 6.7
|
0.3 msec
Standard Deviation 19.7
|
-2.1 msec
Standard Deviation 18.5
|
|
The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Day 12
|
2.1 msec
Standard Deviation 15.0
|
-9.9 msec
Standard Deviation 22.8
|
0.8 msec
Standard Deviation 7.1
|
1.0 msec
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15Population: All treated participants
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Vital Signs: Diastolic Blood Pressure
3 hours post Hemodialysis
|
-3.7 mmHg
Standard Deviation 10.5
|
0.2 mmHg
Standard Deviation 10.9
|
0.1 mmHg
Standard Deviation 9.0
|
0.5 mmHg
Standard Deviation 9.3
|
|
The Change From Baseline in Vital Signs: Diastolic Blood Pressure
24 hours post dose
|
-2.8 mmHg
Standard Deviation 9.9
|
-2.2 mmHg
Standard Deviation 8.7
|
NA mmHg
Standard Deviation NA
No dose of BMS-986177, as Treatment D was Enoxaparin 40 mg by subcutaneous injection
|
NA mmHg
Standard Deviation NA
No dose of BMS-986177, as Treatment A was UFH intravenous infusion
|
PRIMARY outcome
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15Population: All treated participants
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
3 hours post hemodialysis
|
-6.6 mmHg
Standard Deviation 28.2
|
1.1 mmHg
Standard Deviation 24.9
|
-0.2 mmHg
Standard Deviation 17.0
|
-5.8 mmHg
Standard Deviation 18.0
|
|
The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
24 hours post dose
|
-8.4 mmHg
Standard Deviation 23.7
|
-9.2 mmHg
Standard Deviation 17.6
|
NA mmHg
Standard Deviation NA
No dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection
|
NA mmHg
Standard Deviation NA
No dose of BMS-986177, as Treatment A was UFH intravenous infusion
|
PRIMARY outcome
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15Population: All treated participants
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
n=31 Participants
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
n=32 Participants
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
3 hours post hemodialysis
|
4.9 beats/min
Standard Deviation 9.4
|
4.0 beats/min
Standard Deviation 7.4
|
4.5 beats/min
Standard Deviation 6.5
|
3.3 beats/min
Standard Deviation 8.9
|
|
The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
24 hours post dose
|
4.2 beats/min
Standard Deviation 5.6
|
1.1 beats/min
Standard Deviation 7.0
|
NA beats/min
Standard Deviation NA
No dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection
|
NA beats/min
Standard Deviation NA
No dose of BMS-986177, as Treatment A was UFH intravenous infusion
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
Cmax: Maximum observed plasma concentration
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: Cmax
|
1120 ng/mL
Standard Deviation 391.8
|
3342 ng/mL
Standard Deviation 922.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
Time of maximum observed plasma concentration
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: Tmax
|
4.531 h
Standard Deviation 0.933
|
4.855 h
Standard Deviation 1.042
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
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
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
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
|
36112.9 ng.h/mL
Standard Deviation 19802.5
|
—
|
—
|
|
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
|
34028.0 ng.h/mL
Standard Deviation 12191.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
Fraction of unbound drug
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: fu
|
7.644 Percentage
Standard Deviation 1.257
|
7.868 Percentage
Standard Deviation 1.481
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
Maximum observed plasma concentration of free drug
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: Cmaxfu
|
84.32 ng/mL
Standard Deviation 30.14
|
257.9 ng/mL
Standard Deviation 70.40
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
|
783.5 ng.h/mL
Standard Deviation 342.1
|
2782.2 ng.h/mL
Standard Deviation 1537.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequencePopulation: All treated and evaluable participants
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)
Outcome measures
| Measure |
Treatment B
n=32 Participants
Treatment B = BMS-986177 100 mg oral suspension
|
Treatment C
n=31 Participants
Treatment C = BMS-986177 300 mg oral suspension
|
Treatment D
Treatment D = enoxaparin 40 mg by subcutaneous injection
|
Treatment A
Treatments: A = UFH intravenous infusion
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
|
2847.4 ng.h/mL
Standard Deviation 1039.1
|
8558.1 ng.h/mL
Standard Deviation 2509.1
|
—
|
—
|
Adverse Events
Treatment A
Treatment B
Treatment C
Treatment D
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER