A Phase 1, Open Label, Randomized, Two-way Crossover Study to Evaluate the Effect of Multiple Doses of Fidaxomicin on the Single Dose Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by maximum observed concentration
研究概览
简要总结
This study will assess the effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses of fidaxomicin and its metabolite OP-1118.
详细描述
Sequence 1:
Thirteen subjects receive an oral dose of rosuvastatin on Day 1 in Period 1 and on Day 13 in Period 2 and twice-daily oral doses of fidaxomicin on Days 8 to 17 in Period 2, according to the following treatment schedule:
- Period 1: Subjects receive a single oral dose of rosuvastatin on Day 1, followed by a 5-day pharmacokinetic (PK) sampling period.
- Period 2: The same subjects receive fidaxomicin twice daily for 5 days (Days 8 to 12). On Day 13, a single oral dose of rosuvastatin and an oral dose of fidaxomicin is administered simultaneously in the morning. Twice-daily treatment with fidaxomicin continues until the end of Day 17. Subjects are discharged on Day 18 when all assessments are performed and if there are no medical reasons to prolong the stay.
Sequence 2:
Thirteen subjects receive an oral dose of rosuvastatin on Day 6 in Period 1 and on Day 14 in Period 2. Oral doses of fidaxomicin are administered twice daily for 10 days in Period 1, according to the following treatment schedule:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The subject has a Body Mass Index (BMI) range of 18.5 to 30.0 kg/m
- •The subject weighs at least 50 kg at Screening.
- •Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after final study drug administration.
- •The subject must not donate sperm starting at Screening and through-out the study period and for at least 90 days after final study drug administration.
排除标准
- •The subject has a history of or current Clostridium difficile infection.
- •The subject has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- •The subject has an irregular defecation pattern.
研究组 & 干预措施
1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin
干预措施: rosuvastatin (Drug)
1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin
干预措施: fidaxomicin (Drug)
2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin
干预措施: rosuvastatin (Drug)
2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin
干预措施: fidaxomicin (Drug)
结局指标
主要结局
Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by maximum observed concentration
时间窗: Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2)
Cmax (maximum observed concentration)
Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by area under the concentration time curve from time zero extrapolated to infinity
时间窗: Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2)
AUCinf (area under the concentration time curve from time zero extrapolated to infinity)
次要结局
- Effect of multiple doses of fidaxomicin on the single dose pharmacokinetic profile of rosuvastatin(Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2))
- Safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin(Screening (Day -22 to -2) to ESV (7 to 14 days after (early) discharge))
- PK of multiple doses of fidaxomicin and its metabolite OP-1118(Day 9-15 (sequence 1/period2) & Day 2-8 (sequence2/period1))