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Assessment of Effect of Rapastinel on Driving Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814733
Recruitment Status : Completed
First Posted : January 24, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Driving Performance Drug: Rapastinel Drug: Alprazolam Drug: Ketamine Drug: Rapastinel Matched Placebo Drug: Alprazolam Matched Placebo Drug: Ketamine Matched Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : November 5, 2018
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814733


Locations
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United States, California
Collaborative Neuroscience Network
San Clemente, California, United States, 92673
Canada, Ontario
Algorithme Pharma
Aurora, Ontario, Canada, L4G 0A5
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Sheng Fang Su Allergan
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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03814733    
Other Study ID Numbers: RAP-PK-18
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketamine
Alprazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents