Assessment of Effect of Rapastinel on Driving Performance

Driving Performance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814733
• Other study ID #: RAP-PK-18
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2018
• Est. completion date: April 3, 2019

Study information

• Verified date: July 2019
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 3, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Driving Performance

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Algorithme Pharma	Aurora	Ontario
United States	Collaborative Neuroscience Network	San Clemente	California

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc, an affiliate of Allergan plc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	simulated driving performance as measured by SDLP using the CRCDS-MiniSim for rapastinel compared with a clinical comparator (ketamine)		Day 1 of each intervention
Secondary	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".	Day 1 of each intervention
Secondary	Self-perceived safety to drive ("Right now do you feel safe to drive?)		Day 1 of each intervention
Secondary	Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance		Day 1 of each intervention
Secondary	CogScreen SDC Test		Day 1 of each intervention
Secondary	Proportion of abnormal lane exceedance events		Day 1 of each intervention
Secondary	Average Speed (mph)		Day 1 of each intervention
Secondary	Total collisions		Day 1 of each intervention
Secondary	Number of exceeded cornering speed threshold events		Day 1 of each intervention
Secondary	Divided attention: average number of correct responses	Participants are asked to answer periodic questions during the driving simulation.	Day 1 of each intervention
Secondary	Divided attention: average number of errors	Participants are asked to answer periodic questions during the driving simulation.	Day 1 of each intervention
Secondary	Divided attention: average reaction time		Day 1 of each intervention
Secondary	Rapastinel blood plasma concentration		Day 1 of each intervention
Secondary	Adverse Events		Up to 66 days
Secondary	Proportion of abnormal electrocardiograms		Up to 66 days
Secondary	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