A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir
研究概览
简要总结
This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Capable of giving written informed consent
- •Non-tobacco user for at least 3 months prior to selection
- •Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening
排除标准
- •(must NOT meet the following)
- •Infected with Hepatitis A, B, C, or HIV
- •History of or any current medical condition which could impact safety of the participant
- •A positive urine drug test
- •Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week
- •Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100
- •Subjects who have used any drugs or substances known to inhibit or induce cytochrome(CYP) P450 enzymes and/or P-gp within 28 days prior to the first dose and throughout study
- •Subjects who have, within 2 weeks prior to the first dose of study drug, ingested grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family or charbroiled meats
研究组 & 干预措施
Treatment Regimen A
FV-100 400mg OD as a single dose fasted (>/= 8 hours)
干预措施: FV-100 (Drug)
Treatment Regimen B
FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (>/= 8 hours)
干预措施: FV-100 (Drug)
结局指标
主要结局
The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir
时间窗: Two weeks
Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir
The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir
时间窗: Two weeks
Measuring the Cmax, Tmax and AUC for FV-100 pk profile
次要结局
未报告次要终点