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Assessment of Effect of Rapastinel on Driving Performance

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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

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE November 5, 2018
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • 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 ]
  • 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".
  • Self-perceived safety to drive ("Right now do you feel safe to drive?) [ Time Frame: Day 1 of each intervention ]
  • Visual Analog Scale to assess participant's motivation and self-appraisal of their driving performance [ Time Frame: Day 1 of each intervention ]
  • CogScreen SDC Test [ Time Frame: Day 1 of each intervention ]
  • Proportion of abnormal lane exceedance events [ Time Frame: Day 1 of each intervention ]
  • Average Speed (mph) [ Time Frame: Day 1 of each intervention ]
  • Total collisions [ Time Frame: Day 1 of each intervention ]
  • Number of exceeded cornering speed threshold events [ Time Frame: Day 1 of each intervention ]
  • 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.
  • Divided attention: average number of errors [ Time Frame: Day 1 of each intervention ]
    Participants are asked to answer periodic questions during the driving simulation.
  • Divided attention: average reaction time [ Time Frame: Day 1 of each intervention ]
  • Rapastinel blood plasma concentration [ Time Frame: Day 1 of each intervention ]
  • Adverse Events [ Time Frame: Up to 66 days ]
  • Proportion of abnormal electrocardiograms [ Time Frame: Up to 66 days ]
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Effect of Rapastinel on Driving Performance
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Driving Performance
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Rapastinel
  • 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.
    Intervention: Drug: Rapastinel
  • 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.
    Intervention: Drug: Alprazolam
  • 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.
    Intervention: Drug: Ketamine
  • 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.
    Intervention: Drug: Rapastinel Matched Placebo
  • 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.
    Intervention: Drug: Alprazolam Matched Placebo
  • 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.
    Intervention: Drug: Ketamine Matched Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2019)
107
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2019)
96
Actual Study Completion Date  ICMJE April 3, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03814733
Other Study ID Numbers  ICMJE RAP-PK-18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Naurex, Inc, an affiliate of Allergan plc
Study Sponsor  ICMJE Naurex, Inc, an affiliate of Allergan plc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sheng Fang Su Allergan
PRS Account Naurex, Inc, an affiliate of Allergan plc
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP