A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of not less than 50 kilogram (kg)
- •Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening
- •Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1
- •A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1
排除标准
- •Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances
- •Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- •Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- •Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study
- •Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD)
Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state.
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state.
干预措施: JNJ-61803534 (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive JNJ-61803534 or placebo over a 14-day period.
干预措施: JNJ-61803534 (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive JNJ-61803534 or placebo over a 14-day period.
干预措施: Placebo (Drug)
Part 3: Drug-drug Interaction (DDI)
Participants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part.
干预措施: JNJ-61803534 (Drug)
Part 3: Drug-drug Interaction (DDI)
Participants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part.
干预措施: Midazolam (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1
时间窗: Approximately up to 12 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Percentage of Participants With AEs as a Measure of Safety: Part 2
时间窗: Approximately up to 14 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)(Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3))
- Plasma Concentration of Midazolam (Part 3)(Pre-dose and up to Day 18)
- Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)(Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD))