Recruitment

Recruitment Status
Completed

Inclusion Criteria

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 is not visually impaired - normal prescription glasses are accepted
The subject has a normal resting EEG at screening visit
...
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 is not visually impaired - normal prescription glasses are accepted
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus

Exclusion Criteria

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 Criteria

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 is not visually impaired - normal prescription glasses are accepted
The subject has a normal resting EEG at screening visit
...
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 is not visually impaired - normal prescription glasses are accepted
The subject has a normal resting EEG at screening visit
The subject is able to perform tasks with an auditory stimulus

Exclusion Criteria

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.

Tracking Information

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