Assessment of Effect of Rapastinel on Driving Performance
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rapastinel High Dose 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.
|
| Experimental: Rapastinel Low Dose 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.
|
| Active Comparator: 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: 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.
|
| Active Comparator: 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: 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.
|
| Placebo Comparator: Placebo for 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 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 Comparator: Placebo for 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: 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 Comparator: Placebo for 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: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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) [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]
- 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 [Day 1 of each intervention]
Participants are asked to answer periodic questions during the driving simulation.
- 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]
- 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 [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).
Eligibility Criteria
Criteria
Inclusion Criteria
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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.
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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
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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.
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A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator.
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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.
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Expected to work on a rotating shift during their participation in the study.
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Participant works a night shift.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Collaborative Neuroscience Network | San Clemente | California | United States | 92673 |
| 2 | Algorithme Pharma | Aurora | Ontario | Canada | L4G 0A5 |
Sponsors and Collaborators
- Naurex, Inc, an affiliate of Allergan plc
Investigators
- Study Director: Sheng Fang Su, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAP-PK-18