Clinical trial NCT02959060: A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Official title: An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
3. Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
4. Women participants must have documented proof that they are not of childbearing potential.
5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion Criteria:

1. Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Days1-15
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Days1-15
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Days1-15
Secondary outcomes:
measure: Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
timeFrame: Screening- until 30 days after discontinuation of dosing or subject's participation
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: