NCT04171739已完成1 期
A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose of Olorofim.
适应症
干预措施
相关药物
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
- Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
研究概览
简要总结
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.
Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .
Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 32 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
- •Female subjects of child-bearing potential.
- •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
Cohort B
Other
Rifampicin DDI
干预措施: Olorofim (Drug)
Cohort A
Other
Itraconazole DDI
干预措施: Itraconazole oral solution (Drug)
Cohort A
Other
Itraconazole DDI
干预措施: Olorofim (Drug)
Cohort B
Other
Rifampicin DDI
干预措施: Rifampicin Oral Capsule (Drug)
结局指标
主要结局
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
时间窗: 16 days
maximum plasma concentration (Cmax) for olorofim.
时间窗: 16 days
次要结局
- terminal elimination half-life (t½) for olorofim(16 days)
- area under the concentration-time curve to infinity (AUC0-∞) for olorofim(16 days)
- Number of subjects with treatment-related adverse events(23 days)
- Time to Cmax (Tmax) of olorofim(16 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug-Drug Interaction Study With AGMB-129 and Midazolam in Healthy ParticipantsHealthy VolunteersNCT05937386Agomab Spain S.L.14
进行中（未招募）
1 期
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 SubstratesDermatitis AtopicNCT06686628Sanofi23
已完成
1 期
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on WarfarinElevated Lipoprotein(a)Cardiovascular DiseasesNCT03426033Akcea Therapeutics18
已完成
1 期
Mifepristone Drug-Drug Interaction Study With CYP3A InhibitorDrug Interaction PotentiationHealthyNCT03259542Corcept Therapeutics33
已完成
1 期
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active MetaboliteDrug InteractionNCT04902105Emalex Biosciences Inc.38