Assessment of Effect of Rapastinel on Driving Performance

• Status: Completed
• Trial end date: 2019-04-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc
• Treatments: Alprazolam; Ketamine

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.