A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Absolute bioavailability of olorofim (F)
研究概览
简要总结
This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as intact tablets and via NG tube
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
- •males or females of any ethnic origin between 18 and 55 years of age
- •subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m
- •subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
排除标准
- •Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- •Female subjects who are pregnant or lactating.
- •Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
- •Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
- •Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
- •Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
研究组 & 干预措施
oral (fed)
30 mg tablets given after a high fat breakfast (Groups A/B)
干预措施: Olorofim (Drug)
oral (fasted)
30 mg tablets given after an overnight fast (Groups A/B)
干预措施: Olorofim (Drug)
IV
2 h IV infusion (Groups A/B)
干预措施: Olorofim (Drug)
oral (intact tablet)
30 mg tablets (Group C)
干预措施: Olorofim (Drug)
oral (NG tube)
30 mg tablets in water via NG tube (Group C)
干预措施: Olorofim (Drug)
结局指标
主要结局
Absolute bioavailability of olorofim (F)
时间窗: 35 days
maximum plasma concentration (Cmax) for olorofim
时间窗: 35 days
area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim
时间窗: 35 days
次要结局
- Time to Cmax (TMax) for olorofim(35 days)
- area under the concentration time curve to infinity (AUC0-∞) for olorofim(35 days)
- terminal elimination half-life (t½) for olorofim(35 days)
- Number of subjects with treatment-related adverse events(35 days)