Assessment of Effect of Rapastinel on Driving Performance

Registration Number
NCT03814733
Lead Sponsor
Naurex, Inc, an affiliate of Allergan plc
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 of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo for AlprazolamAlprazolam Matched PlaceboParticipants 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.
Placebo for KetamineKetamine Matched PlaceboParticipants 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.
Placebo for RapastinelRapastinel Matched PlaceboParticipants 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.
Rapastinel High DoseRapastinelParticipants 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.
Rapastinel Low DoseRapastinelParticipants 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.
AlprazolamAlprazolamParticipants 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.
KetamineKetamineParticipants 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.
Primary Outcome Measures
NameTimeMethod
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)Day 1 of each intervention
Secondary Outcome Measures
NameTimeMethod
Karolinska Sleepiness Scale (KSS)Day 1 of each intervention

The KSS is a participant self-reported measure of situational sleepiness and provides an assessment of alertness/sleepiness. The KSS is a 9-point categorical scale, where 1 = "extremely alert" and 9 = "extremely sleepy-fighting sleep".

Self-perceived safety to drive ("Right now do you feel safe to drive?)Day 1 of each intervention
CogScreen SDC TestDay 1 of each intervention
Average Speed (mph)Day 1 of each intervention
Divided attention: average number of errorsDay 1 of each intervention

Participants are asked to answer periodic questions during the driving simulation.

Divided attention: average reaction timeDay 1 of each intervention
Adverse EventsUp to 66 days
Proportion of abnormal electrocardiogramsUp to 66 days
simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)Day 1 of each intervention
Number of exceeded cornering speed threshold eventsDay 1 of each intervention
Rapastinel blood plasma concentrationDay 1 of each intervention
Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performanceDay 1 of each intervention
Proportion of abnormal lane exceedance eventsDay 1 of each intervention
Total collisionsDay 1 of each intervention
Divided attention: average number of correct responsesDay 1 of each intervention

Participants are asked to answer periodic questions during the driving simulation.

Columbia-Suicide Severity Rating ScaleUp to 66 days

The C-SSRS is a clinician-ratedinstrument that reports theseverity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (least severe) to 5 (most severe).

Trial Locations

Locations (2)

Collaborative Neuroscience Network

🇺🇸

San Clemente, California, United States

Algorithme Pharma

🇨🇦

Aurora, Ontario, Canada

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