Recruitment

Recruitment Status
Completed

Inclusion Criterias

The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus
...
The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus
The subject is not visually impaired - normal prescription glasses are accepted

Exclusion Criterias

The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.

Summary

Conditions
Healthy Men
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Inclusion Criterias

The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus
...
The subject has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 pm and midnight.
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus
The subject is not visually impaired - normal prescription glasses are accepted

Exclusion Criterias

The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.
The subject has worked shifts, including night duty, or has travelled across >3 time zones <2 weeks prior to the first dose of IMP.

Locations

Rennes, 35000
Rennes, 35000

Tracking Information

NCT #
NCT02072278
Collaborators
Not Provided
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com