A Single Center, Open Label, Phase 1 Drug-Drug Interaction Study to Investigate the Effects of Voclosporin on the Pharmacokinetics of Simvastatin in Healthy Volunteers
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
- Pharmacokinetics of simvastatin and simvastatin acid (Cmax)
研究概览
简要总结
A single-center, open-label, Phase 1, drug-drug interaction study to investigate the effect of voclosporin on the pharmacokinetics of simvastatin and simvastatin acid in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent
- •Healthy male or female subjects aged >=18 and <=55 years
- •Body mass index >=18.0 and <32 kg/m2
排除标准
- •Abnormal ECG and/or prolonged QT interval
- •Subjects using nicotine products within 3 months prior to screening
- •Subjects who have lost or donated >450 mL of whole blood or blood products within 30 days prior to the Screening Visit.
- •Use of any prescription medication within 14 days prior to the first dose of study medication, or any over-the-counter products (including natural health products, e.g., food supplements, vitamins, herbal supplements) within 7 days prior to the first dose of study medication, except for topical products without significant systemic absorption.
- •Use of any drugs or substances known to induce or inhibit hepatic drug metabolism within 28 days prior to administration of the study medication
- •Consumption of grapefruit or grapefruit juice, pomelo or star fruit within 7 days of first dose of study drug on Day 1
- •Use of hormonal contraception or hormone replacement therapy within 14 days prior to first dose of study drug.
- •No COVID-19 vaccines are allowed within 28 days prior to first dose of study drug.
- •History of or current alcohol abuse or drug addiction
- •Subjects who are pregnant or breast feeding
- •Subjects who have received any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to screening.
- •Subjects who have any significant health issues as deemed by their treating physician/investigator
研究组 & 干预措施
Voclosporin/Simvastatin
Subjects will receive a single oral dose of 40 mg simvastatin (given as two 20 mg tablets) in the morning of Day 1 and Day 8.
Subjects will receive voclosporin administered as an oral 23.7 mg dose (three 7.9 mg capsules) twice-daily for 7 days from the morning of Day 2 until the evening of Day 8.
干预措施: Simvastatin (Drug)
Voclosporin/Simvastatin
Subjects will receive a single oral dose of 40 mg simvastatin (given as two 20 mg tablets) in the morning of Day 1 and Day 8.
Subjects will receive voclosporin administered as an oral 23.7 mg dose (three 7.9 mg capsules) twice-daily for 7 days from the morning of Day 2 until the evening of Day 8.
干预措施: Voclosporin (Drug)
结局指标
主要结局
Pharmacokinetics of simvastatin and simvastatin acid (Cmax)
时间窗: 9 days
To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Maximum observed concentration (Cmax).
Pharmacokinetics of simvastatin and simvastatin acid (AUC)
时间窗: 9 days
To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Area under the concentration-time curve (AUC) time zero to last quantifiable concentration.
次要结局
- Pharmacokinetics of voclosporin (Cmax)(9 days)
- Pharmacokinetics of voclosporin (Tmax)(9 days)
- Pharmacokinetics of voclosporin (AUC)(9 days)
- Number of participants with abnormal laboratory test results(Up to 2 weeks)
- 12-Lead Electrocardiogram Assessment(Up to 2 weeks)
- Pharmacokinetics of voclosporin (Ctrough)(9 days)
- Pharmacokinetics of voclosporin (CL/F)(9 days)
- Number of participants with abnormal vital signs(Up to 2 weeks)