A Phase 1 First in Human Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety-Number of patients with adverse events
研究概览
简要总结
The purpose of this study is to study the safety and tolerability of a single dose of PLX5622 in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by humans.
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
- Triple (Participant, 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
- •Healthy adult male and female subjects, 18-65 years of age inclusive
- •BMI 18 to 32 kg/m2 inclusive
- •Female subjects must be surgically sterile or postmenopausal for the past year and have a negative urine pregnancy test. Male subjects and their partners of childbearing potential must be willing to use two methods of contraception, one of which must be a barrier method (e.g. condom) for up to 90 days after the last study drug administration.
- •Willing and able to remain in the clinical research unit as required by the protocol
- •Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- •History or presence of any disease, medical condition, or surgery, which may have an effect on drug absorption, metabolism, distribution, or excretion of the investigational product
- •Laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis) that the investigator believes show clinically relevant significant abnormalities for the normal reference range
- •Any abnormality in the ECG (including QTc ≥450 msec) that in the opinion of the investigator increases the risk of participating in the study
- •History or presence of alcoholism or drug abuse within the year prior to dosing
- •Tobacco use, either current or within 3 months prior to dosing
- •Use of any prescription medications or herbal remedies within 14 days prior to dosing, or use of over-the-counter medications or vitamins within 7 days prior to dosing, unless approved by the Sponsor
- •Donation of whole blood within 56 days prior to the study
- •Plasma donation within 7 days prior to the study
- •Participation in an investigational device study or receipt of an investigational drug within 4 weeks prior to dosing
- •Positive urine test for drugs of abuse
- •Confirmed HIV, hepatitis B, or hepatitis C infection
研究组 & 干预措施
single oral dose of 200 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
single oral dose of 400 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
single oral dose of 800 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
single oral dose of 1600 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
single oral dose of 1000 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
single oral dose of 1400 mg PLX5622
6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.
干预措施: PLX5622 (Drug)
Placebo
2 patients per cohort will be randomly assigned to take placebo. 12 patients total will be randomized to take placebo in this study.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety-Number of patients with adverse events
时间窗: 7 days
Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
Tolerability-Number of patients with adverse events
时间窗: 7 days
Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for tolerability issues/abnormal changes in the above mentioned tests.
次要结局
- Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve(7 days)
- Pharmacokinetic evaulation: Measurement of Peak Concentration(7 days)
- Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant(7 Days)