A Double-Blind, Placebo- and Positive-Controlled, Randomized, Partial 6-way Crossover Study to Investigate the Pharmacodynamics and Pharmacokinetics of CEP-26401 (5, 25, and 125 μg) Following Single-Dose Administration to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Paired Associate Learning (PAL) Test
研究概览
简要总结
This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is able to give legal informed consent and understand the requirements of the study and communicate with the investigator in the local spoken language.
- •The subject is willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide their written informed consent to participate in the study.
- •The subject is a man or woman, 18 to 50 years of age, inclusive.
- •The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- •The subject has skin type I to IV (very light to olive).
- •The subject is in a good health as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
- •Female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) test (at screening) and check-in and be willing and able to use one of the protocol-specified double-barrier methods of birth control.
- •The subject is able to complete the screening process within 4 weeks prior to study drug administration.
排除标准
- •The subject has a cognitive performance outside of reference values at screening.
- •The subject smokes, is a tobacco user, currently uses nicotine products.
- •The subject has a known hypersensitivity to donepezil, modafinil, irdabisant, or one of the excipients, or has any significant food or drug allergies.
- •The subject is a female who is pregnant or lactating.
- •The subject has an intraocular pressure greater than 22 mm Hg.
- •The subject is suffering from, or has a clinically significant history of one or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the investigator, might pose additional risk to the subject by participation in the study or confound the results of the study.
- •The subject has a laboratory abnormality judged by the investigator as clinically significant, or measurements outside of the defined range
- •Other exclusion criteria apply; please contact the investigator for more information.
研究组 & 干预措施
CEP-26401 5 μg, 25 μg, 125 μg, placebo
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 in each of the dose options: 5, 25 and 125 μg, and one dose that only contains the placebos.)
干预措施: CEP-26401 (Drug)
CEP-26401 5 μg, 25 μg, 125 μg, placebo
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 in each of the dose options: 5, 25 and 125 μg, and one dose that only contains the placebos.)
干预措施: Placebo (Drug)
CEP-26401 5 μg, 25 μg, placebo, donepezil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 25 μg, and donepezil at 10mg and one dose that only contains the placebos.)
干预措施: CEP-26401 (Drug)
CEP-26401 5 μg, 25 μg, placebo, donepezil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 25 μg, and donepezil at 10mg and one dose that only contains the placebos.)
干预措施: donepezil hydrochloride (Drug)
CEP-26401 5 μg, 25 μg, placebo, donepezil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 25 μg, and donepezil at 10mg and one dose that only contains the placebos.)
干预措施: Placebo (Drug)
CEP-26401 5 μg, 125 μg, placebo, modafinil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 125 μg, and modafinil at 200mg) and one dose that only contains the placebos.)
干预措施: CEP-26401 (Drug)
CEP-26401 5 μg, 125 μg, placebo, modafinil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 125 μg, and modafinil at 200mg) and one dose that only contains the placebos.)
干预措施: modafinil (Drug)
CEP-26401 5 μg, 125 μg, placebo, modafinil
Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 125 μg, and modafinil at 200mg) and one dose that only contains the placebos.)
干预措施: Placebo (Drug)
结局指标
主要结局
Paired Associate Learning (PAL) Test
时间窗: Baseline to Hour 22
Rapid Visual Information Processing (RVIP) Test
时间窗: Baseline to Hour 22
Spatial Working Memory Test
时间窗: Baseline to Hour 22
Stop Signal Task (SST)
时间窗: Baseline to Hour 22
Adaptive tracking Test
时间窗: Baseline to Hour 22
Body sway Test
时间窗: Baseline to Hour 22
Leeds Sleep Evaluation Questionnaire (LSEQ)
时间窗: Baseline to Hour 22
Leiden Maze Test (LMT)
时间窗: Baseline to Hour 22
n-Back Working Memory Test
时间窗: Baseline to Hour 22
Polysomnography (PSG) Test
时间窗: Baseline to Hour 22
Saccadic Eye Movements
时间窗: Baseline to Hour 22
Single-Choice Reaction Time
时间窗: Baseline to Hour 22
Smooth Pursuit Eye Movements
时间窗: Baseline to Hour 22
Visual Analog Scales (VAS)
时间窗: Baseline to Hour 22
Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects
次要结局
- area under the drug concentration-time curve (AUC0-t)(Baseline to Hour 22)
- maximal observed plasma drug concentration (Cmax)(Baseline to Hour 22)
- time to maximum observed plasma drug concentration (tmax)(Baseline to Hour 22)
- Summary of participants with Adverse Events(From signing of the consent form to Day 30)