A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- AUC of edasalonexent with midazolam and deflazacort
研究概览
简要总结
Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 [CYP]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.
详细描述
This is an open-label, fixed-sequence DDI and cardiodynamic study in healthy adult subjects.
Twenty-six (26), healthy, adult male and female (non-childbearing potential) subjects will be enrolled.
Screening of subjects will occur within 28 days prior to the first dosing.
To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 [CYP]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.
Visit assessments include Clinical laboratory tests, Safety ECGs and Cardiodynamic ECGs. Subjects will be housed on Day -3 of Period 1, until after the 24-hour blood draw and/or study procedures are completed on Day 12 of Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female (of non-childbearing potential), 18-55 years of age, inclusive at Screening
- •Non-smoker
- •Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 at Screening
- •Medically healthy with no clinically significant medical history
- •Ability to swallow multiple capsules/tablets.
- •Ability to understand the study procedures, willing and able to comply with the protocol
排除标准
- •History or presence of clinically significant medical condition or disease
- •History or presence of hypersensitivity to edasalonexent or excipients based upon known allergies to compounds of a similar class such as salicylates, fish oil, eicosapentaenoic acid, or DHA
- •History or presence of hypersensitivity to midazolam, deflazacort, or related compounds (e.g., steroids or their formulation including lactose).
- •Participation in another clinical study within 30 days prior to the first dosing
研究组 & 干预措施
Treatment A
2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.
干预措施: Midazolam 2 MG/ML (Drug)
Treatment A
2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.
干预措施: Deflazacort 36Mg Tab (Drug)
Treatment B
2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11.
干预措施: Edasalonexent 2000 mg TID (Drug)
Treatment B
2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11.
干预措施: Midazolam 2 MG/ML (Drug)
Treatment B
2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11.
干预措施: Deflazacort 36Mg Tab (Drug)
结局指标
主要结局
AUC of edasalonexent with midazolam and deflazacort
时间窗: 12 Days
次要结局
- QTc interval with edasalonexent(12 Days)
- Number of participants with reported treatment-related adverse events(12 days)