AntithromboticPhase 1/2NCT03000673

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

A Phase 1/2 study testing Enoxaparin, unfractionated heparin (UFH) and BMS-986177 in people with Antithrombotic, run by Bristol-Myers Squibb at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease treated with hemodialysis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Antithrombotic
What is being tested?: Enoxaparin, unfractionated heparin (UFH) and BMS-986177
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 3 sitesUnited States
Study dates: 23 May 2017to 23 Oct 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Subjects receiving dialysis through central venous catheters
History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease in the past 3 months
Current or recent (within 3 months of study drug administration) gastrointestinal disease or surgery, which by the judgment of the Investigator, may increase a subject's risk of gastrointestinal bleeding or interfere with absorption of study drug (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrointestinal surgery).
Any major surgery within 12 weeks of study drug administration
History of significant head injury within the last 2 years, including subjects with base of skull fractures
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Davita Clinical Research
Lakewood, Colorado, 80228
Davita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

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

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

Conditions: Antithrombotic
Being tested: Enoxaparin, unfractionated heparin (UFH), BMS-986177

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnoxaparinDrug
Specified dose of Enoxaparin on specified days
unfractionated heparin (UFH)Drug
Specified dose of UFH on specified days
BMS-986177Drug
Specified dose of BMS-986177 on specified day

Study groups in NCT03000673
Study group	Role	What they receive
Dose Sequence 1	Active comparator	UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin Receives: Drug: Enoxaparin; Drug: unfractionated heparin (UFH); Drug: BMS-986177
Dose Sequence 2	Active comparator	BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2 Receives: Drug: Enoxaparin; Drug: unfractionated heparin (UFH); Drug: BMS-986177
Dose Sequence 3	Active comparator	BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1 Receives: Drug: Enoxaparin; Drug: unfractionated heparin (UFH); Drug: BMS-986177
Dose Sequence 4	Active comparator	Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH Receives: Drug: Enoxaparin; Drug: unfractionated heparin (UFH); Drug: BMS-986177

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85*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;
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
LIVER \& KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25*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;
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): 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;
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): 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
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): 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
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : 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
Measured: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
The 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.
Measured: Days -3 to -1, Days 1, 5, 8, and 12.
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.
Measured: Days -3 to -1, Days 1, 5, 8, and 12.
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.
Measured: Days -3 to -1, Days 1, 5, 8, and 12.
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.
Measured: Days -3 to -1, Days 1, 5, 8, and 12.
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.
Measured: Days -3 to -1, Days 1, 5, 8, and 12
The Change From Baseline in Vital Signs: Diastolic Blood Pressure
Measured: 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)
Measured: 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: Heart Rate (Beats/Min)
Measured: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 201723 Oct 2017

First posted22 Dec 2016 (estimated)
Study start23 May 2017
Primary completion23 Oct 2017
Study completion23 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AntithromboticStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03000673
Sponsor's protocol ID: CV010-010
Status last verified: Dec 2020
First submitted: 20 Dec 2016
Last updated: 29 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Antithrombotic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis
ClinicalTrials.gov ID: NCT03000673
Acronym / sponsor ID: CV010-010
Conditions: Antithrombotic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 23 May 2017 (actual)
Primary completion: 23 Oct 2017 (actual)
Study completion: 23 Oct 2017 (actual)
First posted: 22 Dec 2016 (estimated)
Results: Posted 29 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Dose Sequence 1	Active comparator	Drug: Enoxaparin, Drug: unfractionated heparin (UFH), Drug: BMS-986177UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin
Dose Sequence 2	Active comparator	Drug: Enoxaparin, Drug: unfractionated heparin (UFH), Drug: BMS-986177BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2
Dose Sequence 3	Active comparator	Drug: Enoxaparin, Drug: unfractionated heparin (UFH), Drug: BMS-986177BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1
Dose Sequence 4	Active comparator	Drug: Enoxaparin, Drug: unfractionated heparin (UFH), Drug: BMS-986177Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnoxaparinSpecified dose of Enoxaparin on specified days	Drug	Dose Sequence 1, Dose Sequence 2, Dose Sequence 3, Dose Sequence 4
unfractionated heparin (UFH)Specified dose of UFH on specified days	Drug	Dose Sequence 1, Dose Sequence 2, Dose Sequence 3, Dose Sequence 4
BMS-986177Specified dose of BMS-986177 on specified day	Drug	Dose Sequence 1, Dose Sequence 2, Dose Sequence 3, Dose Sequence 4

Primary outcome

The Number of 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)
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
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.
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
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.
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
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
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.)
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.
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
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.
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
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.
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
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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: Heart Rate (Beats/Min)
Time frame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15

7 secondary outcomes

Pharmacokinetic Parameters of BMS-986177: Cmax
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: Tmax
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: fu
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: Cmaxfu
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
Time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence

Results and safety

Results posted to the registry on 29 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABCD	7	6
Sequence BDAC	9	9
Sequence CADB	7	7
Sequence DCBA	9	9

Primary outcome: The Number of 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). Number. Unit: Participants

Measure	Treatment B n = 32	Treatment C n = 31	Treatment D n = 31	Treatment A n = 32
Adverse Events	4	4	3	2
Serious Adverse Events	0	0	0	0
Adverse Events Leading to Discontinuations	0	0	0	0
Deaths	0	0	0	0

Population analysed: All treated participants

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

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.. Count of participants. Unit: Participants

Measure	Treatment B n = 32	Treatment C n = 31	Treatment D n = 31	Treatment A n = 32
Hematology I Hemoglobin (G/DL) Abnormal low	3	3	2	1
Hematocrit (%) Abnormal low	3	4	2	2
Platelet Count (X10*9 C/L) Abnormal low	1	1	2	1
Leukocytes (X10*3 C/UL) Abnormal low	2	1	0	2
Leukocytes (X10*3 C/UL): Abnormal high	0	0	1	1
Neutrophils (Absolute) (X10*3 C/UL)	0	0	2	1
Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low	3	4	3	5
Monocytes (Absolute) (X10*3 C/UL) Abnormal high	0	0	0	0

Population analysed: All treated participants with evaluable test results

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

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.. Count of participants. Unit: Participants

Measure	Treatment B n = 32	Treatment C n = 31	Treatment D n = 31	Treatment A n = 32
ALP (U/L) Abnormal high	0	0	0	1
AST (U/L) Abnormal high	0	0	0	0
AST (U/L) Not reported	0	0	1	0
ALT (U/L) Abnormal high	0	0	1	0
Bilirubin, Total (MG/DL) Abnormal high	0	0	1	0
Bilirubin, Direct (MG/DL) Abnormal high	1	1	1	3
Bilirubin, Direct (MG/DL), Not reported	1	0	1	0
Blood Urea Nitrogen (MG/DL) Abnormal high	0	1	1	0

Population analysed: All treated participants with evaluable test results

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

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. Count of participants. Unit: Participants

Measure	Treatment C n = 31	Treatment D n = 31	Treatment A n = 32
Sodium, Serum (MEQ/L), Abnormal low	0	0	0
Sodium, Serum (MEQ/L), Abnormal high	0	0	0
Potassium, Serum (MEQ/L), Abnormal low	0	0	0
Potassium, Serum (MEQ/L), Abnormal high	1	1	1
Potassium, Serum (MEQ/L), Not reported	0	1	0
Chloride, Serum (MEQ/L) Abnormal low	0	0	0
Chloride, Serum (MEQ/L) Abnormal high	0	0	0
Chloride, Serum (MEQ/L) Not reported	0	0	1

Population analysed: All treated participants with evaluable test results

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of the patient's written consent to participate in the study until 30 days after discontinuation of dosing. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Treatment B	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Treatment C	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Treatment D	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Enoxaparin, unfractionated heparin (UFH) and BMS-986177 in people with Antithrombotic, run by Bristol-Myers Squibb at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of 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)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03000673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.