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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel High Dose | Experimental | 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 | Experimental | 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 | Active Comparator | 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 | Active Comparator | 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 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine) | 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". |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sheng Fang Su | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network | San Clemente | California | 92673 | United States | ||
| Algorithme Pharma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34423904 | Derived | Su S, Kay G, Hochadel T, Rojo J, Christopher Stein J, Boinpally R, Periclou A. A randomized, multicenter trial assessing the effects of rapastinel compared to ketamine, alprazolam, and placebo on simulated driving performance. Clin Transl Sci. 2022 Jan;15(1):255-266. doi: 10.1111/cts.13145. Epub 2021 Nov 7. |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
| D000525 | Alprazolam |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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 Alprazolam | Placebo Comparator | 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 | Placebo Comparator | 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 | Drug | 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 | Drug | 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 Matched Placebo | Drug | 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 Matched Placebo | Drug | 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 Matched Placebo | Drug | 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. |
|
| Day 1 of each intervention |
| Self-perceived safety to drive ("Right now do you feel safe to drive?) | 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 |
| CogScreen SDC Test | Day 1 of each intervention |
| Proportion of abnormal lane exceedance events | Day 1 of each intervention |
| Average Speed (mph) | Day 1 of each intervention |
| Total collisions | Day 1 of each intervention |
| Number of exceeded cornering speed threshold events | Day 1 of each intervention |
| Divided attention: average number of correct responses | Participants are asked to answer periodic questions during the driving simulation. | Day 1 of each intervention |
| Divided attention: average number of errors | Participants are asked to answer periodic questions during the driving simulation. | Day 1 of each intervention |
| Divided attention: average reaction time | Day 1 of each intervention |
| Rapastinel blood plasma concentration | Day 1 of each intervention |
| Adverse Events | Up to 66 days |
| Proportion of abnormal electrocardiograms | 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). | Up to 66 days |
| Aurora |
| Ontario |
| L4G 0A5 |
| Canada |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |