A Phase 1 interventional study of Rapastinel and Alprazolam in Driving Performance, sponsored by Naurex, Inc, an affiliate of Allergan plc. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Naurex, Inc, an affiliate of Allergan plc (part of AbbVie) · Phase 1, Interventional, and Other
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.
Naurex, Inc, an affiliate of Allergan plc is the lead sponsor of 20 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
First submitted before Naurex, Inc became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria
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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
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.
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.
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.
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.
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.
Simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with placebo and positive control (alprazolam)
Time frame: Day 1 of each intervention
simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)
Time frame: Day 1 of each intervention
Karolinska Sleepiness Scale (KSS)
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".
Time frame: Day 1 of each intervention
Self-perceived safety to drive ("Right now do you feel safe to drive?)
Time frame: Day 1 of each intervention
Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance
Time frame: Day 1 of each intervention
CogScreen SDC Test
Time frame: Day 1 of each intervention
Proportion of abnormal lane exceedance events
Time frame: Day 1 of each intervention
Average Speed (mph)
Time frame: Day 1 of each intervention
Total collisions
Time frame: Day 1 of each intervention
Number of exceeded cornering speed threshold events
Time frame: Day 1 of each intervention
Divided attention: average number of correct responses
Participants are asked to answer periodic questions during the driving simulation.
Time frame: Day 1 of each intervention
Divided attention: average number of errors
Participants are asked to answer periodic questions during the driving simulation.
Time frame: Day 1 of each intervention
Divided attention: average reaction time
Time frame: Day 1 of each intervention
Rapastinel blood plasma concentration
Time frame: Day 1 of each intervention
Adverse Events
Time frame: Up to 66 days
Proportion of abnormal electrocardiograms
Time frame: Up to 66 days
Columbia-Suicide Severity Rating Scale
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).
Time frame: Up to 66 days
Plan to share: Undecided
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GLYX-13 peptide
Naurex, Inc, an affiliate of Allergan plc →