Status:
COMPLETED
Assessment of Effect of Rapastinel on Driving Performance
Lead Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Conditions:
Driving Performance
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 5,000 miles (about 8,000 km) per year for the previous 3 years.
- Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
- Exclusion Criteria
- A history within 2 years of, or current intervention for, a sleeping disorder (including excessive snoring, obstructive sleep apnea) or a chronic painful condition that interferes with the participant's sleep.
- A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator.
- Participant has traveled across 1 or more time zones (transmeridian travel) in the 14 days before study intervention or is expected to travel across 1 or more time zones during the study.
- Expected to work on a rotating shift during their participation in the study.
- Participant works a night shift.
Exclusion
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03814733
Start Date
November 5 2018
End Date
April 3 2019
Last Update
July 11 2019
Active Locations (2)
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1
Collaborative Neuroscience Network
San Clemente, California, United States, 92673
2
Algorithme Pharma
Aurora, Ontario, Canada, L4G 0A5