CompletedPhase 1ketamine

Assessment of Effect of Rapastinel on Driving Performance

NCT ID

NCT03814733

Target Enrollment

107 participants

Start Date

2018-11-05

Est. Completion

2019-04-03

About This Study

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 of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.

Conditions Studied

Driving Performance

Interventions

•Rapastinel
•Alprazolam
•Ketamine
•Rapastinel Matched Placebo
•Alprazolam Matched Placebo
•Ketamine Matched Placebo

Eligibility

Age:21 Years - 65 Years

Healthy Volunteers:Yes

View full eligibility criteria

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.

Study Locations (2)

Collaborative Neuroscience Network

San Clemente, California, United States

Algorithme Pharma

Aurora, Ontario, Canada