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Completed

NCT Number: NCT03814733

Assessment of Effect of Rapastinel on Driving Performance

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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Key information

Conditions

Driving Performance

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Algorithme Pharma, Aurora, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.
  • A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator.
  • 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.
  • Expected to work on a rotating shift during their participation in the study.
  • Participant works a night shift.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Karolinska Sleepiness Scale (KSS)

    Time frame: 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".

  3. Self-perceived safety to drive ("Right now do you feel safe to drive?)

    Time frame: Day 1 of each intervention

  4. Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance

    Time frame: Day 1 of each intervention

  5. CogScreen SDC Test

    Time frame: Day 1 of each intervention

  6. Proportion of abnormal lane exceedance events

    Time frame: Day 1 of each intervention

  7. Average Speed (mph)

    Time frame: Day 1 of each intervention

  8. Total collisions

    Time frame: Day 1 of each intervention

  9. Number of exceeded cornering speed threshold events

    Time frame: Day 1 of each intervention

  10. Divided attention: average number of correct responses

    Time frame: Day 1 of each intervention

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

  11. Divided attention: average number of errors

    Time frame: Day 1 of each intervention

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

  12. Divided attention: average reaction time

    Time frame: Day 1 of each intervention

  13. Rapastinel blood plasma concentration

    Time frame: Day 1 of each intervention

  14. Adverse Events

    Time frame: Up to 66 days

  15. Proportion of abnormal electrocardiograms

    Time frame: Up to 66 days

  16. Columbia-Suicide Severity Rating Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Naurex, Inc, an affiliate of Allergan plc

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Double-dummy, Placebo-controlled, 5-period, Crossover Study Assessing the Effects of Rapastinel Compared to Alprazolam, Ketamine, and Placebo on Simulated Driving Performance in Normal Healthy Participants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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