NCT01092845已完成1 期
Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)
研究概览
简要总结
PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •Healthy male subjects between the ages of 18 and 55 years
- •Body Mass Index (BMI) between 17.5 and 30.5 kg/m2
- •Total body weight >50 kg
排除标准
- •History of any active sleep disorder
- •History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years
- •Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening
研究组 & 干预措施
PF-04457845 followed by placebo
Experimental
干预措施: PF-04457845 / matched placebo (Drug)
Placebo followed by PF-04457845
Experimental
干预措施: PF-04457845 / matched placebo (Drug)
结局指标
主要结局
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)
时间窗: 3 days
次要结局
- Total sleep time(3 days)
- Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO)(3 days)
- Latency to persistent sleep(3 days)
- Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG(3 days)
- Minutes of REM sleep time(3 days)
- Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))(3 days)
- Percentage of total sleep time spent in Stage 1 sleep(3 days)
- Plasma concentrations of PF-04457845(3 days)
- Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG(3 days)
- Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep(3 days)
- Percentage of total sleep time spent in Stage 2 sleep(3 days)
- Percentage of total sleep time spent in Stage 3-4 sleep(3 days)
- Number of arousals after sleep onset (NASO)(3 days)
研究者
研究点 (1)
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