A Blinded, Placebo- and Comparator-Controlled Three-way Crossover Study to Investigate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Number of participants with adverse events as a measure of safety
研究概览
简要总结
The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the study medication) of JNJ-40411813.
详细描述
This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (effect of the study medication will be compared with the effect of placebo [inactive substance]), comparator-controlled (effect of the study medication will be compared with the effect of FDA approved and marketed active substance [citalopram]), and 3-way crossover (method used to switch participants from one treatment arm to another treatment arm) study. This study will be double-blinded for treatment with placebo and JNJ-40411813; however, it will be open label (all people know the identity of the intervention) for treatment with citalopram. This study will consist of screening phase (within 28 days prior to the start of study medication), treatment phase, and follow-up phase (approximately 14 days after the last administration of study medication). Participants will be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period 1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled in this study (3 participants in each sequence). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be evaluated throughout the study duration. The total duration of study participation for a participant will be approximately 10 Weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18 and 29.9 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])
排除标准
- •Significant history of or current significant medical illness including (but not limited to) liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers clinically significant
- •History of a relevant sleep disorder and / or receiving treatment for sleep disorders
- •Regular or periodic use of benzodiazepines
- •Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies at screening
- •Positive urine screen for drugs of abuse and positive alcohol breath test at screening or administration of the study medication
- •Use of any prescription medication or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of start of study medication
研究组 & 干预措施
Sequence 1
Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 1
Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 1
Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
Sequence 3
Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
Sequence 2
Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 2
Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 2
Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
Sequence 3
Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 3
Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 4
Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 4
Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 4
Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
Sequence 5
Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 5
Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 5
Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
Sequence 6
Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: JNJ-40411813 (Drug)
Sequence 6
Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Placebo (Drug)
Sequence 6
Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days.
干预措施: Citalopram (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety
时间窗: Up to Week 10
Rapid Eye Movement (REM) sleep latency
时间窗: Day 3 and Day 4
REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).
Total duration of Rapid Eye Movement (REM) sleep
时间窗: Day 3 and Day 4
Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2.
Total time spent in deep sleep
时间窗: Day 3 and Day 4
Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of stages score as 3 or stage 4 divided by 2.
次要结局
- Time in bed(Day 3 and Day 4)
- Latency to persistent sleep(Day 3 and Day 4)
- Sleep onset latency(Day 3 and Day 4)
- Total sleep time(Day 3 and Day 4)
- Sleep efficiency(Day 3 and Day 4)
- Number of awakenings(Day 3 and Day 4)
- Time spent awake after sleep onset(Day 3 and Day 4)
- Duration of REM Sleep(Day 3 and Day 4)
- Duration of Stage 1 Sleep(Day 3 and Day 4)
- Duration of Stage 2 Sleep(Day 3 and Day 4)
- Number of REM blocs(Day 3 and Day 4)
- Peak plasma concentration of JNJ-40411813(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))
- Time to reach the peak plasma concentration of JNJ-40411813(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))
- Area under the plasma concentration of JNJ-40411813-time curve from 0 to t hours post dosing(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))
- Area under the plasma concentration of JNJ-40411813-time curve from 0 to infinity post dosing(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))
- Elimination rate constant of JNJ-40411813(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))
- Terminal half-life of JNJ-40411813(Day 3 (predose; 1, 3, 6, 14 and 16 hours post dose))