Phase 2
N=32
A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
Antithrombotic
Bottom Line
View on ClinicalTrials.gov: NCT03000673 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death — 4; 4; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enoxaparin (Drug); unfractionated heparin (UFH) (Drug); BMS-986177 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death |
4; 4; 3; 2; 0; 0 | — |
| PRIMARY The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation |
3; 3; 2; 1; 3; 4 | — |
| PRIMARY The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing |
0; 0; 1; 1; 2; 2 | — |
| PRIMARY The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies |
1; 1; 0; 0; 0; 0 | — |
| PRIMARY The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate |
1.8; 1.4; 0.4; -0.1; -2.1; 2.0 | — |
| PRIMARY The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate |
-1.3; -25.0; -6.9; 13.6; 12.6; -5.8 | — |
| PRIMARY The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate |
-1.1; 5.7; -0.2; -3.1; -0.3; -0.2 | — |
| PRIMARY The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate |
-3.7; -1.6; -3.1; 3.9; 8.4; -7.4 | — |
| PRIMARY The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate |
-3.2; 1.7; -1.0; 5.7; 5.1; -4.9 | — |
| PRIMARY The Change From Baseline in Vital Signs: Diastolic Blood Pressure |
-3.7; 0.2; 0.1; 0.5; -2.8; -2.2 | — |
| PRIMARY The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg) |
-6.6; 1.1; -0.2; -5.8; -8.4; -9.2 | — |
| PRIMARY The Change From Baseline in Vital Signs: Heart Rate (Beats/Min) |
4.9; 4.0; 4.5; 3.3; 4.2; 1.1 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Cmax |
1120; 3342 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Tmax |
4.531; 4.855 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24) |
10406.6; 36112.9; 10533.4; 34028.0 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: fu |
7.644; 7.868 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Cmaxfu |
84.32; 257.9 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu |
783.5; 2782.2 | — |
| SECONDARY Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7) |
2847.4; 8558.1 | — |
Summary
To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease treated with hemodialysis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Subjects with ESRD treated with hemodialysis 3 times a week for at least 3 months prior enrollment.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
- Women must not be breastfeeding
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) BMS-986177 plus 5 half-lives of study treatment (2 days) plus 30 days (duration of ovulatory cycle) for a total of 32 days post-treatment completion
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) BMS-986177 plus 5 half-lives of the study treatment plus 90 days (duration of sperm turnover) for a total of 92 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.
Exclusion Criteria
- Subjects receiving dialysis through central venous catheters
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease in the past 3 months
- Current or recent (within 3 months of study drug administration) gastrointestinal disease or surgery, which by the judgment of the Investigator, may increase a subject's risk of gastrointestinal bleeding or interfere with absorption of study drug (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrointestinal surgery).
- Any major surgery within 12 weeks of study drug administration
- History of significant head injury within the last 2 years, including subjects with base of skull fractures
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03000673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.