A Randomized, Double-Blind, Placebo- and Active-Controlled, 4-Period Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
概览
- 阶段
- 1 期
- 干预措施
- Placebo tablet matching lemborexant
- 疾病 / 适应症
- Healthy Participants
- 发起方
- Eisai Inc.
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change of standard deviation of lateral position (SDLP) during an on-road driving test
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance
详细描述
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline. The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 - Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit. Participants will be randomized to 1 of 12 sequences in an incomplete blocks design.
研究者
入排标准
入选标准
- •Healthy, male or female, aged 21 years or older at Screening
- •Regular time spent in bed between 7.0 and 8.5 hours per night
- •Regular bedtime, defined as the time the participant attempts to fall asleep, between 22:00 hours and 01:00 hours, and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 hours and 09:00 hours
- •Body mass index (BMI) ≥18 and \<31 kg/m2 at Screening
- •Subjective sleep onset latency (sSOL) \<30 minutes and subjective wake after sleep onset (sWASO) \<60 minutes on the Sleep Diary
- •At least 3 years of experience driving at least 3000 km per year
- •Holds a valid license to drive a vehicle in the European Union (EU) as confirmed at the Screening visit
- •Has driving ability during the practice driving test that is judged to be adequate by the driving instructor
- •Able to communicate adequately (written and verbal) in either Dutch or English as determined by the investigator
排除标准
- •A current complaint or diagnosis of insomnia disorder (per either The Diagnostic and Statistical Manual of Mental Disorders Version IV \[DSM-IV\] or Version 5 \[DSM-5\] criteria), sleep-related breathing disorder, periodic limb movement disorder, restless legs or narcolepsy, or an exclusionary score on a subscale of the SLEEP50
- •Habitually naps more than 3 times per week
- •Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[B-hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- •Females of childbearing potential who:
- •Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation.
- •Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexually active during the study period or for 28 days after study drug discontinuation.
- •Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal \[amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause\] or have been sterilized surgically \[ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing\]).
- •Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation.
- •Clinically significant illness that requires medical treatment between Screening and Baseline
- •Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment
研究组 & 干预措施
Treatment A
Treatment A is a placebo tablet matching lemborexant and placebo tablet matching zopiclone on nights in the clinic; placebo tablet matching lemborexant on nights at home.
干预措施: Placebo tablet matching lemborexant
Treatment A
Treatment A is a placebo tablet matching lemborexant and placebo tablet matching zopiclone on nights in the clinic; placebo tablet matching lemborexant on nights at home.
干预措施: Placebo tablet matching zopiclone
Treatment B
Treatment B is zopiclone 7.5 mg tablet and placebo tablet matching lemborexant on nights in the clinic; placebo tablet matching lemborexant on nights at home.
干预措施: Placebo tablet matching lemborexant
Treatment B
Treatment B is zopiclone 7.5 mg tablet and placebo tablet matching lemborexant on nights in the clinic; placebo tablet matching lemborexant on nights at home.
干预措施: Zopiclone 7.5 mg
Treatment C
Treatment C is lemborexant 2.5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 2.5 mg tablet on nights at home.
干预措施: Placebo tablet matching zopiclone
Treatment C
Treatment C is lemborexant 2.5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 2.5 mg tablet on nights at home.
干预措施: Lemborexant 2.5 mg
Treatment D
Treatment D is lemborexant 5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 5 mg tablet on nights at home.
干预措施: Placebo tablet matching zopiclone
Treatment D
Treatment D is lemborexant 5 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 5 mg tablet on nights at home.
干预措施: Lemborexant 5 mg
Treatment E
Treatment E is lemborexant 10 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 10 mg tablet on nights at home.
干预措施: Placebo tablet matching zopiclone
Treatment E
Treatment E is lemborexant 10 mg tablet and placebo tablet matching zopiclone on nights in the clinic; lemborexant 10 mg tablet on nights at home.
干预措施: Lemborexant 10 mg
结局指标
主要结局
Change of standard deviation of lateral position (SDLP) during an on-road driving test
时间窗: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
次要结局
- Outliers on SDLP(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Outliers on number of lapses(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Number of lapses on the driving test(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Plasma concentration of lemborexant(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Standard deviation of lateral position (SDLP) during an on-road driving test, by age group(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Plasma concentration of S-zopiclone(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Percentage of participants who never started a scheduled driving test or who stopped prematurely(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)
- Number of lapses on the driving test, by age group(Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72)