NCT03814733

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

November 15, 2018

Last Update Submit

July 9, 2019

Conditions

Driving Performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • 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

  • 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

  • +11 more secondary outcomes

Study Arms (7)

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.

Drug: Rapastinel

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.

Drug: Rapastinel

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.

Drug: Alprazolam

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.

Drug: Ketamine

Placebo for Rapastinel

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.

Drug: Rapastinel Matched Placebo

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.

Drug: Alprazolam Matched Placebo

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.

Drug: Ketamine Matched Placebo

Interventions

RapastinelDRUG

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 High DoseRapastinel Low Dose
AlprazolamDRUG

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
KetamineDRUG

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
Rapastinel Matched PlaceboDRUG

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
Alprazolam Matched PlaceboDRUG

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
Ketamine Matched PlaceboDRUG

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

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Collaborative Neuroscience Network

San Clemente, California, 92673, United States

Location

Algorithme Pharma

Aurora, Ontario, L4G 0A5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34423904DERIVED

MeSH Terms

Interventions

GLYX-13 peptideAlprazolamKetamine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sheng Fang Su

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

January 24, 2019

Study Start

November 5, 2018

Primary Completion

March 29, 2019

Study Completion

April 3, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

CA(1)US(1)