Assessment of Effect of Rapastinel on Driving Performance
Status and phase
Completed
Phase 1
Conditions
Driving Performance
Treatments
Drug: Ketamine
Drug: Ketamine Matched Placebo
Drug: Rapastinel
Drug: Rapastinel Matched Placebo
Drug: Alprazolam Matched Placebo
Drug: Alprazolam
Details and patient eligibility
About
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.
Enrollment
107 patients
Sex
All
Ages
21 to 65 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
107 participants in 7 patient groups, including a placebo group
Rapastinel High Dose
Experimental group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Rapastinel
Rapastinel Low Dose
Experimental group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Rapastinel
Alprazolam
Active Comparator group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Alprazolam
Ketamine
Active Comparator group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Ketamine
Placebo for Rapastinel
Placebo Comparator group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Rapastinel Matched Placebo
Placebo for Alprazolam
Placebo Comparator group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Alprazolam Matched Placebo
Placebo for Ketamine
Placebo Comparator group
Description:
Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Treatment:
Drug: Ketamine Matched Placebo
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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