A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-40346527 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food.
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.
详细描述
JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study will be the first study in which JNJ-40346527 is given to humans. This study is being conducted in three parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) studies comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers. Part 3 is an open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic period and three follow-up visits. For Part 2, the participation period is a maximum of 83 days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For Part 3, the participation period is a maximum of 59 days, including a screening visit, two 4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300, 600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50, 150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between doses.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be generally in good health
- •Have negative result for HIV,hepatitis B, and hepatitis C
- •Non-smoker for at least 6 months
- •Females must be of non childbearing potential,i.e., either: surgically sterile (bilateral tubal ligation or removal of ovaries and/or uterus or partial hysterectomy at least 6 months prior to dosing), or naturally postmenopausal for at least 2 years, with negative blood and urine pregnancy tests prior to dosing
- •must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after the study is completed
排除标准
- •History of alcohol or drug abuse
- •Average consumption of more than 5 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
- •History of any type of significant allergies (eg, anaphylaxis, prominent respiratory and skin symptoms)
- •Use of St.John's Wort (hypericin) for 30 days before first dosing
- •Use of any type of hormone replacement therapy for 30 days before the first dose
- •history of receiving a live virus vaccination within the past month or plans to receive vaccination with a live virus vaccine within 2 weeks following the last dose of medication
- •receipt of an experimental drug or medical device within the last month
研究组 & 干预措施
001
JNJ-40346527/Placebo Single oral dose of JNJ-40346527 (either 10 50 150 300 600 or 1000mg) or Placebo
干预措施: JNJ-40346527/Placebo (Drug)
002
JNJ-40346527/Placebo JNJ-40346527 once daily oral dose for 14 days (either 50 150 300 500 or 750mg) or Placebo
干预措施: JNJ-40346527/Placebo (Drug)
003
JNJ-40346527 JNJ-40346527 150mg one dose either fasting (or with food) then after 7 days off treatment JNJ-40346527 150mg either with food (or fasting)
干预措施: JNJ-40346527 (Drug)
结局指标
主要结局
To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food.
时间窗: from time of dosing to follow-up (28-35 days)
次要结局
- To assess the pharmacodynamics (explores what the drug does to the body) of JNJ-40346527.(Part 1: Days 1 & 2; Part 2: Days 1, 7, 14, and 15)