A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential effectiveness for treating insomnia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy as assessed by medical history and safety evaluations performed at screening
- •Has a body mass index between 18 and 30 kilogram per square meter (kg/m2) and body weight not less than 50 kg
- •Must be willing and able to abide by the prohibitions and restrictions of the study, including requirements for contraception
- •Women must not be of childbearing potential by either being postmenapausal or permanently sterilized
- •Part 2 Only: Maintains a regular sleep-wake cycle as measured by sleep diaries and a watch that measures activity
- •Has a habitual (majority of days) bedtime and duration of sleep that meet the study requirements
排除标准
- •Current or history of clinically significant medical or psychiatric illness, or recent major surgery or blood loss/donation
- •Any current sleep-wake disorder, recent night shift work, or history of insomnia within the last 5 years
- •Man who has a pregnant female partner
- •Woman who is breastfeeding
- •Is participating or has participated within the last 3 months in a study with an investigational drug or medical device
- •Tests positive or has a history of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other active liver disease
- •Drug or alcohol abuse within the last 5 years, nicotine use within the last 3 months, or tests positive for alcohol, drugs of abuse, or nicotine
- •Routinely consumes an excessive amount of caffeine
研究组 & 干预措施
Part 1 Single Dose
Part 1 single daytime oral dose of JNJ-48816274 or placebo. Doses of JNJ-48816274 will start at 5 milligram (mg) and increase sequentially to a maximum dose of 250 mg.
干预措施: JNJ-48816274 (Drug)
Part 1 Single Dose
Part 1 single daytime oral dose of JNJ-48816274 or placebo. Doses of JNJ-48816274 will start at 5 milligram (mg) and increase sequentially to a maximum dose of 250 mg.
干预措施: Placebo (Drug)
Part 2 Crossover Sleep Study
Part 2 single nighttime oral dose of JNJ-48816274 or placebo administered during each of 3 or 4 crossover periods separated by 7-9 days. The doses of JNJ-48816274 will be selected based on data from Part 1 (not to exceed 250 mg).
干预措施: JNJ-48816274 (Drug)
Part 2 Crossover Sleep Study
Part 2 single nighttime oral dose of JNJ-48816274 or placebo administered during each of 3 or 4 crossover periods separated by 7-9 days. The doses of JNJ-48816274 will be selected based on data from Part 1 (not to exceed 250 mg).
干预措施: Placebo (Drug)
Part 3 Repeated Dose (Optional)
Part 3 daytime oral dose of JNJ-48816274 or placebo administered once daily for 7 consecutive days. Doses will be determined based on data from Part 1, and may increase sequentially (not to exceed 250 mg/day).
干预措施: JNJ-48816274 (Drug)
Part 3 Repeated Dose (Optional)
Part 3 daytime oral dose of JNJ-48816274 or placebo administered once daily for 7 consecutive days. Doses will be determined based on data from Part 1, and may increase sequentially (not to exceed 250 mg/day).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 14 days after last dose in Part 1 (approximately 5.5 weeks)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
时间窗: Days 1-2 in Part 1
Maximum Observed Plasma Concentration (Cmax)
时间窗: Day 1 in Part 1
Time to Reach the Maximum Plasma Concentration (Tmax)
时间窗: Day 1 in Part 1
Elimination Half Life (t1/2)
时间窗: Days 1-2 in Part 1
Mean Karolinska Sleepiness Scale score
时间窗: Day 1 in Part 1
A 1-item questionnaire completed by participants to rate their degree of sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep' (9).
次要结局
- Area Under the Plasma Concentration vs. Time Curve in Subjects who are Fasted Predose vs. Those Fed a Meal(Part 1: Days 1-2)
- Correlation Between Plasma Levels of JNJ-48816274 and Karolinska Sleepiness Scale Score(Day 1 of Parts 1 and 3)
- Mean Total Sleep Time by 8-hour overnight Polysomnography(Part 2: Days 1-2 of each of 3 or 4 crossover periods)
- Mean Latency to Persistent Sleep by 8-hour overnight Polysomnography(Part 2: Days 1-2 of each of 3 or 4 crossover periods)
- Mean Leeds Sleep Evaluation Questionnaire (LSEQ) Score(Part 2: Day 2 of each of 3 or 4 crossover periods)
- Mean Subjective Quality of Sleep Questionnaire (SQSQ) Item Scores(Part 2: Day 2 of each of 3 or 4 crossover periods)
- Mean Karolinska Sleepiness Scale score(Part 2: Days 1-2 of each of 3 or 4 crossover periods; Part 3: Days 1-7)
- Correlation Between Plasma Levels of JNJ-48816274 and Duration of Sleep as Measured by 8-hour Overnight Polysomnography(Part 2: Days 1-2 of each of 3 or 4 crossover periods)