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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo for Alprazolam Alprazolam Matched Placebo 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. Placebo for Ketamine Ketamine Matched Placebo 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. Placebo for Rapastinel Rapastinel Matched Placebo 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. Rapastinel High Dose Rapastinel 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. Rapastinel Low Dose Rapastinel 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. Alprazolam Alprazolam 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. Ketamine Ketamine 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Test Day 1 of each intervention Average Speed (mph) Day 1 of each intervention Divided attention: average number of errors Day 1 of each intervention Participants are asked to answer periodic questions during the driving simulation.
Divided attention: average reaction time Day 1 of each intervention Adverse Events Up to 66 days Proportion of abnormal electrocardiograms Up 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 events Day 1 of each intervention Rapastinel blood plasma concentration Day 1 of each intervention Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance Day 1 of each intervention Proportion of abnormal lane exceedance events Day 1 of each intervention Total collisions Day 1 of each intervention Divided attention: average number of correct responses Day 1 of each intervention Participants are asked to answer periodic questions during the driving simulation.
Columbia-Suicide Severity Rating Scale Up 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