A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax) in Plasma for casdatifan
研究概览
简要总结
The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female 18-55 years of age, inclusive, at the screening visit.
- •Male participants must be vasectomized
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg, at the screening visit
- •Able to swallow multiple tablets and/or capsules.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Casdatifan-Itraconazole-Phenytoin
Participants will receive casdatifan, itraconazole, and phenytoin.
干预措施: Casdatifan (Drug)
Casdatifan-Itraconazole-Phenytoin
Participants will receive casdatifan, itraconazole, and phenytoin.
干预措施: Itraconazole (Drug)
Casdatifan-Itraconazole-Phenytoin
Participants will receive casdatifan, itraconazole, and phenytoin.
干预措施: Phenytoin (Drug)
结局指标
主要结局
Maximum Concentration (Cmax) in Plasma for casdatifan
时间窗: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan
时间窗: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
Time to Maximum Concentration (Tmax) in Plasma for casdatifan
时间窗: Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to 26.2 weeks)
- Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3)(Up to 18 days)