Clinical trial NCT03000673: A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
Official title: A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Antithrombotic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
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)
measure: The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
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.
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
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.
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
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
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
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.
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
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.
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
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.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
timeFrame: Days -3 to -1, Days 1, 5, 8, and 12.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
timeFrame: Days -3 to -1, Days 1, 5, 8, and 12.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
timeFrame: Days -3 to -1, Days 1, 5, 8, and 12.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
timeFrame: Days -3 to -1, Days 1, 5, 8, and 12.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
timeFrame: Days -3 to -1, Days 1, 5, 8, and 12
measure: The Change From Baseline in Vital Signs: Diastolic Blood Pressure
timeFrame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
measure: The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
timeFrame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
measure: The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
timeFrame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
Secondary outcomes:
measure: Pharmacokinetic Parameters of BMS-986177: Cmax
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: Tmax
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: fu
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: Cmaxfu
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
timeFrame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Davita Clinical Research
state: Colorado
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: