A Phase 1, 3-Part Study to Evaluate the Effect of CYP3A4 Inhibition and Induction on the Pharmacokinetics of Clemizole and the Effect of Clemizole on the Pharmacokinetics of CYP2C19, CYP3A4, and CYP2B6 Substrates in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Cmax of Midazolam
研究概览
简要总结
This is a 3-part, drug-drug interaction study in healthy participants. Each part is designed as a 2-period, fixed-sequence and can be conducted concurrently.
Part 1 will assess the effect of itraconazole on the pharmacokinetics (PK) of EPX-100. Part 2 will assess the effect of phenytoin on the PK of EPX-100. Part 3 will assess the effect of EPX-100 on the PK of omeprazole, midazolam, and bupropion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- •Body mass index ≥18.0 and ≤32.0 kilograms per square meter(kg/m^2) within 28 days prior to first dosing.
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 Investigator or designee.
- •History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol
研究组 & 干预措施
Part 1 - Itraconazole
Treatment A (Period 1): EPX-100 on Day 1.
Treatment B (Period 2): itraconazole twice daily (BID) on Day 1; then once daily (QD) on Days 2-5, with EPX-100 administered approximately 2 hours after itraconazole dosing on Day 5.
干预措施: EPX-100 (Drug)
Part 3 - Omeprazole, Midazolam, and Bupropion
Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3.
Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15.
干预措施: Midazolam (Drug)
Part 1 - Itraconazole
Treatment A (Period 1): EPX-100 on Day 1.
Treatment B (Period 2): itraconazole twice daily (BID) on Day 1; then once daily (QD) on Days 2-5, with EPX-100 administered approximately 2 hours after itraconazole dosing on Day 5.
干预措施: Itraconazole (Drug)
Part 2 - Phenytoin
Treatment C (Period 1): EPX-100 on Day 1. Treatment D (Period 2): phenytoin three times daily (TID) on Days 1 to Day 14, with EPX-100 coadministered on the morning of Day 14.
干预措施: EPX-100 (Drug)
Part 2 - Phenytoin
Treatment C (Period 1): EPX-100 on Day 1. Treatment D (Period 2): phenytoin three times daily (TID) on Days 1 to Day 14, with EPX-100 coadministered on the morning of Day 14.
干预措施: Phenytoin (Drug)
Part 3 - Omeprazole, Midazolam, and Bupropion
Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3.
Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15.
干预措施: EPX-100 (Drug)
Part 3 - Omeprazole, Midazolam, and Bupropion
Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3.
Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15.
干预措施: Bupropion (Drug)
Part 3 - Omeprazole, Midazolam, and Bupropion
Treatment E (Period 1): omeprazole on Day 1; midazolam on Day 2; bupropion on Day 3.
Treatment F (Period 2): EPX-100 BID on Days 1-18 with omeprazole coadministered on the morning of Day 12; midazolam coadministered on the morning of Day 14; bupropion coadministered on the morning of Day 15.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Cmax of Midazolam
时间窗: Up to Day 15
AUC0-t of Bupropion
时间窗: Up to Day 19
AUC0-t of Midazolam
时间窗: Up to Day 15
AUC0-inf of Midazolam
时间窗: Up to Day 15
Area Under The Concentration-time Curve (AUC), from Time 0 to the Last Observed Non-zero Concentration (AUC0-t) Of EPX-100
时间窗: Up to Day 15
AUC From Time 0 extrapolated to infinity (AUC0-inf) of EPX-100
时间窗: Up to Day 15
Maximum Observed Concentration (Cmax) of EPX-100
时间窗: Up to Day 15
AUC0-t of Omeprazole
时间窗: Up to Day 15
AUC0-inf of Omeprazole
时间窗: Up to Day 15
Cmax of Omeprazole
时间窗: Up to Day 15
AUC0-inf of Bupropion
时间窗: Up to Day 19
Cmax of Bupropion
时间窗: Up to Day 19
次要结局
- Number of Participants with Treatment Emergent Adverse Events(Up to 12 Weeks)