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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
48
Tablet form taken orally at bedtime.
Tablet form taken orally at bedtime.
7.5 mg tablet taken orally at bedtime.
Maastricht University
Maastricht, Netherlands
Change of standard deviation of lateral position (SDLP) during an on-road driving test
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Number of lapses on the driving test
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on SDLP
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Outliers on number of lapses
Time frame: 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
Time frame: 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
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of lemborexant
Time frame: 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
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
Plasma concentration of S-zopiclone
Time frame: Day 2, Day 9, Day 23, Day 30, Day 44, Day 51, Day 65, and Day 72
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2.5 tablet taken orally at bedtime.
5 mg tablet taken orally at bedtime.
10 mg tablet taken orally at bedtime.