Status and phase
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About
This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.
Full description
After being informed about the study and potential risks, all patients giving written informed conset will undergo 2 screening visits to determine eligibility for study entry. Selected participants will then stay twice in the lab (active treatment condition and placebo condition), each visit lasting approximately 4 days. Participants will stay awake across the night and sleep during the day. Only the experimental condition will be different between the two visits (lemborexant or placebo). These experimental visits will be double-blind, in counterbalanced order and separated by an interval of at least 2 weeks (washout period).
Enrollment
Sex
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Volunteers
Inclusion criteria
Participants must fulfill all of the following inclusion criteria to be eligible for inclusion in this study:
Men or women aged between 30 and 60 years, inclusive
Be willing and able to give informed consent for study participation
Participants must not have done shiftwork in the past year
Normal vital signs values are: oral body temperature between 36.1 and 37.5 ºC (95 and 99.5 °F), supine SBP between 90 and 140 mmHg inclusive; supine DBP between 55 and 90 mmHg inclusive; heart rate between 50 and 100 bpm inclusive.
Be willing to comply with all study requirements and procedures for the duration of the study, including refraining from consuming alcohol 48 hours prior to each experimental visit and grapefruit products (juice or fruit itself), Seville orange, lime, pomelo, carambola and pomegranate during all the duration of the study (from Visit 1 to Visit 4).
Women who:
Men with women partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops.
Self-reported bedtime was between 9 pm and midnight on 4-7 nights per week.
Exclusion criteria
Participants must not meet any of the following exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups, including a placebo group
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Central trial contact
Veronique Daneault, M.Sc, Ph.D.; Alex Desautels, M.D., Ph.D.
Data sourced from clinicaltrials.gov
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