A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
- •Non-childbearing potential female subjects
- •Male subjects and female partners must agree to use at least 2 methods of contraception
- •Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.
排除标准
- •Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
- •Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
- •Subjects with a positive urine screen for drugs of abuse
- •Subjects with a history of regular alcohol consumption
- •Subjects treated with an investigational drug within 30 days
- •For Part A only: Subjects with 12-lead ECG QTcF >450 msec (males) or QTcF >470 msec (females) at the Screening Visit
- •Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
- •Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
- •Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
- •Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
- •Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit
研究组 & 干预措施
Part A
Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.
干预措施: telaprevir formulation A (Drug)
Part A
Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.
干预措施: telaprevir Formulation B (Drug)
Part A
Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.
干预措施: telaprevir Formulation C (Drug)
Part A
Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state.
干预措施: telaprevir Formulation D (Drug)
Part B
Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state
干预措施: telaprevir formulation A (Drug)
Part B
Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state
干预措施: telaprevir Formulation B (Drug)
Part B
Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state
干预措施: telaprevir Formulation C (Drug)
Part B
Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state
干预措施: telaprevir Formulation D (Drug)
结局指标
主要结局
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
时间窗: Up to 57 days
• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)
时间窗: Up to 57 Days
次要结局
- The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms(Up to 57days)
- Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir(Up to 57 Days)