NCT02949999已完成1 期
A Single-center, Double-blind, Placebo-controlled, Randomized, Ascending Multiple-dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Voclosporin in Healthy Japanese Volunteers
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
- 40
- 试验地点
- 1
- 主要终点
- Mean, median and standard deviation of laboratory parameters. Incidence of laboratory parameters outside of normal range
研究概览
简要总结
The study is a single-centre, double-blind, placebo controlled, randomized, ascending multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic profiles of voclosporin.
详细描述
Ten subjects will be randomized into each of four treatment groups to receive approximately 0.25, 0.5, 1.0, 1.5mg/kg/dose of voclosporin vs placebo. For Day 1, subjects will be given oral treatment once a day; Day 2, subjects will not be given any oral treatment; Day 3-12, subjects will be given oral treatment twice a day; Day 13, subjects will be given oral treatment once a day. The duration of the study takes about 21 days (including follow up assessments).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese males and females by birth aged 20 - 45 years inclusive
- •Females who are non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or from 35 days prior to study entry (i.e. Day -2) until 30 days following study completion/discharge and using an approved method of contraception.
- •Males who are sterile or from the time of dose administration until 30 days following their dose administration and using an approved method of contraception.
- •Screening FSH >40 IU/ml in self-identified post-menopausal female subjects.
- •Weight must be >55 kg but <100 kg, with BMI of 18-30 kg/m2 inclusive.
- •Healthy as defined by normal screening assessments, including full medical history, complete physical examination, vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis. Laboratory results must be within the reference range or considered to be not clinically significant by the Principal Investigator with agreement of the Medical Monitor. Lab tests may be repeated during the screening period as appropriate.
- •Capable to participate, provide informed consent and comply with study procedures and restrictions
- •Must agree to refrain from consumption of grapefruit juice from at least one week prior to dosing until all follow-up procedures are completed.
排除标准
- •History of drug abuse and/or alcoholism in the previous 2 years.
- •Positive urine drug test, urine cotinine test or alcohol breath test at screening.
- •Positive for Hepatitis B, Hepatitis C or HIV.
- •QTcB >430 msec in males, or QTcB >450 msec in females in 12-lead ECG tracing at screening.
- •Blood donation within 56 days prior to dosing and plasma donation within 7 days prior to first dosing.
- •Hemoglobin value < 12 g/dL.
- •Current smokers (smoking cigarettes and other forms of tobacco or nicotine use must be stopped at least 90 days before screening).
- •History of alcohol consumption averaging more than 2 drinks per day in a week (1 drink is 12 oz beer, 4 oz wine or 1.5oz of spirits) within 6 months prior to screening. Alcohol-containing foods or beverages are prohibited within 7 days prior to study entry and during the entire study duration.
- •Use of any drugs known to inhibit or induce hepatic drug metabolism (i.e. inducers include barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; inhibitors include antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- •Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing
- •Use of prescription medication within 14 days prior to first dosing or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to first dosing, except for topical products without systemic absorption, or is likely to need medication during the study period.
- •Clinically significant abnormal liver function, abnormal renal function, active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid, current or recent infections, history of hypertension and history of malignancy.
- •Any reason which, in the opinion of the Principal Investigator or the Sponsor's medical monitor, would prevent the subject from participating in the study.
研究组 & 干预措施
0.25mg/kg voclosporin
Experimental
0.25mg/kg voclosporin BID.
干预措施: Voclosporin (Drug)
0.5mg/kg voclosporin
Experimental
0.5mg/kg voclosporin BID
干预措施: Voclosporin (Drug)
1.0mg/kg voclosporin
Experimental
1.0mg/kg voclosporin BID
干预措施: Voclosporin (Drug)
1.5mg/kg voclosporin
Experimental
1.5mg/kg voclosporin BID
干预措施: Voclosporin (Drug)
Placebo voclosporin
Placebo Comparator
placebo BID
干预措施: Voclosporin (Drug)
结局指标
主要结局
Mean, median and standard deviation of laboratory parameters. Incidence of laboratory parameters outside of normal range
时间窗: 21 days
Safety of voclosporin after single and multiple oral ascending doses
Incidence of treatment emergent adverse events
时间窗: 21 days
Tolerability of voclosporin after single and multiple oral ascending doses
次要结局
- Pharmacokinetics of voclosporin after single and multiple oral ascending doses(21 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy SubjectsDrug SafetyNCT01519531Madrigal Pharmaceuticals, Inc.48
已完成
1 期
Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy VolunteersChronic PainNCT05714254AstraZeneca36
已完成
1 期
A Clinical Trial of BGT-002 Tablets in Subjects With Nonalcoholic SteatohepatitisNASHNCT06491576Burgeon Therapeutics Co., Ltd.48
已完成
1 期
Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NACNoise-Induced Hearing LossHearing LossSensorineural Hearing LossNCT02259595Otologic Pharmaceutics, Inc.32
已完成
1 期
A Dose-escalation Clinical Trial After Multiple Dosing of HL217 Eye Drop in Healthy Male SubjectsHealthy SubjectsNCT03648346Hanlim Pharm. Co., Ltd.16