ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum plasma concentrations (Cmax) of RDC-0313
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
详细描述
This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 65 years of age
- •Body mass index of 19-30 kg/m2 at screening
- •If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
- •If subject is male, he must agree to reduce the risk of a female partner becoming pregnant
排除标准
- •Pregnancy and/or currently breastfeeding
- •Clinically significant medical condition or observed abnormalities
- •Clinically significant illness within 30 days of the first study drug administration
- •History of opioid dependence
- •Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
- •Positive resolut for any serology test performed at screening
- •Use of alcohol-, caffeine-, or xanthine-containing products
- •Tobacco use within 90 days before the first study drug administration
- •Participation in a clinical trial within 30 days before screening
- •Requirement of a special diet other than vegetarian, or significant food allergy or intolerance
研究组 & 干预措施
RDC-0313, 5mg
5 mg of RDC-0313; single dose
干预措施: RDC-0313 (Drug)
RDC-0313, 15 mg
15 mg RDC-0313; single dose
干预措施: RDC-0313 (Drug)
RDC-0313, 25mg
25 mg RDC-0313; single dose
干预措施: RDC-0313 (Drug)
RDC-0313, 50 mg
50 mg RDC-0313; single dose
干预措施: RDC-0313 (Drug)
RDC-0313, 75 mg
75 mg RDC-0313; single dose
干预措施: RDC-0313 (Drug)
Placebo
volume-match placebo; single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum plasma concentrations (Cmax) of RDC-0313
时间窗: 12 weeks
次要结局
- Clinically significant abnormal laboratory findings(12 weeks)