An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Effect of Oral Doses of SCY-078 (Ibrexafungerp) on the Pharmacokinetics of Dabigatran Administered Orally to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of DAB administered with SCY-078, AUC
研究概览
简要总结
This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.
详细描述
The two-period crossover study will consist of two treatments administered in random order. Treatments will be separated by a minimum of 10 day wash-out (between last dose in the first period and first dose in the subsequent period). Healthy male and female subjects will will be enrolled to assess the effects on a single dose of dabigatran mesylate (DAB).
Subjects will be screened within 4 weeks prior to dosing and randomized to a treatment sequence (AB or BA) in a crossover fashion.
Treatment A: Single oral 150mg dose of DAB. Treatment B: Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750mg on Day and Day 2; and single oral AM doses of SCY-078 750mg on Day 3 and Day. On Day 3, a single 150mg dose of DAB will be administered 1 hour after the AM dose of SCY-078.
Subjects will fast overnight after being admitted to the clinic on Day -1 and will remain in the clinic until the final procedures are complete.
Twenty eight male and female subjects between 18 and 55 years (inclusive) will be enrolled into the study. Subjects who discontinue may be replaced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent).
- •has a Body Mass Index (BMI) 18.0 - 32 kg/m2 at the prestudy (screening) visit. BMI is calculated by taking the subject's weight in kg and dividing by the subject's height in meters, squared.
- •is judged to be in good physical and mental health based on medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug. Subjects will be enrolled at the discretion of the investigator.
- •is a nonsmoker and has not used nicotine or nicotine containing products for 6 months prior to screening.
- •is willing and able to sign the informed consent and understands the study procedures and agrees to comply with all restrictions and participate in the study.
- •is not pregnant or lactating (for women of childbearing potential) and must agree to use adequate double barrier birth control.
排除标准
- •has a contra-indication to PRADAXA® (dabigatran etexilate mesylate)
- •has a prior history of convulsions, or hemorrhagic disease
- •has a history of peptic ulcer disease that is currently being treated.
- •is pregnant or is lactating
- •has a history of uncontrolled or unstable cardiovascular, respiratory, renal, hepatic, gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.
- •has had any major surgery within 30 days of dosing with study drug.
- •has consumed Seville or blood oranges, grapefruit or grapefruit juice, or mulberry juice as well as vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) or charbroiled meats from 4 days prior to the dose of study medication.
- •has consumed any alcohol within 7 days prior to the dose of study medication.
- •is a smoker or has used tobacco or any nicotine-containing products within the 6 months prior to screening.
- •has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing.
- •has participated in a clinical investigation of any drug, biological, or other investigational therapy, device or procedure 30 days before dosing
- •has a history of an allergic reaction to SCY-078 or any of its excipients. or is allergic to PRADAXA® (dabigatran etexilate mesylate), or its inactive ingredients.
研究组 & 干预措施
Treatment A
Single oral 150-mg dose of DAB on Day 1 AM.
干预措施: DAB (Drug)
Treatment B
Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.
干预措施: SCY-078 plus DAB (Drug)
结局指标
主要结局
Pharmacokinetics of DAB administered with SCY-078, AUC
时间窗: 17 days
AUC0-48 of DAB when taken with SCY-078
次要结局
- Safety and tolerability of oral dosing of combination of DAB with SCY-078(7 weeks)
- Pharmacokinetics of DAB administered with SCY-078, Cmax(17 days)
- Pharmacokinetics of DAB administered with SCY-078, Tmax(17 days)
- Pharmacokinetics of DAB administered with SCY-078, Half Life(17 Days)