A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
试验速览
- 阶段
- 1 期
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of SHX-001 (Tmax)
研究概览
简要总结
The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.
详细描述
SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present a current depressive episode of at least 8 weeks
- •Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening
- •Agree to use adequate methods of contraception during the study (and for X days after discharge)
排除标准
- •A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry.
- •Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant.
- •Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication
- •A history of drug abuse or dependence within 180 days of screening
- •A febrile illness within 5 days prior to the first dose of study medication.
- •A known hypersensitivity to ketamine
- •A history of use ketamine for Major Depressive Disorder and did not respond to ketamine
- •Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)
研究组 & 干预措施
SHX-001 Active Low Dose
Ketamine transdermal patch
干预措施: SHX-001 Active low dose (Drug)
Placebo
placebo transdermal patch
干预措施: Placebo (Drug)
SHX-001 Active high dose
ketamine transdermal patch
干预措施: SHX-001 Active High dose (Drug)
结局指标
主要结局
Pharmacokinetics of SHX-001 (Tmax)
时间窗: 1 week
Time of maximum observed plasma concentration
Pharmacokinetics of SHX-001 (T1/2)
时间窗: 1 week
Apparent terminal half-life
Pharmacokinetics of SHX-001 (Cmax)
时间窗: 1 week
Maximum observed plasma concentration
次要结局
- Anti-depressive effects of SHX-001(1 week)