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A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03459612
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research unit. Screening must be completed within 28 days before the start of the study. Follow-up will be completed about one week after discharge.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lasmiditan Drug: Placebo Drug: Diphenhydramine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, 4-Period Cross-Over Study Assessing the Duration of Effect of Lasmiditan on Simulated Driving Performance in Healthy Volunteers
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : June 23, 2018
Actual Study Completion Date : June 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo administered orally in one of four study periods.
Drug: Placebo
Administered orally

Experimental: Lasmiditan Dose 1
Lasmiditan Dose 1 administered orally in one of four study periods.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Experimental: Lasmiditan Dose 2
Lasmiditan Dose 2 administered orally in one of four study periods.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Active Comparator: Diphenhydramine
Diphenhydramine administered orally in one of four study periods.
Drug: Diphenhydramine
Administered orally




Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP) [ Time Frame: 8 hours after dosing in each period ]
    SDLP measured by Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)

  2. SDLP [ Time Frame: 12 hours after dosing in each period ]
    SDLP measured by CRCDS-MiniSim

  3. SDLP [ Time Frame: 24 hours after dosing in each period ]
    SDLP measured by CRCDS-MiniSim


Secondary Outcome Measures :
  1. Karolinska Sleepiness Scale (KSS) Score [ Time Frame: 8, 12, and 24 hours after dosing in each period ]
    The KSS is a 9-point scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). Lower score is better.

  2. CogScreen Symbol Digit Coding (SDC) Test: Number of Correct Responses [ Time Frame: 8, 12, and 24 hours after dosing in each period ]
    CogScreen SDC Test

  3. Number of Total Collisions [ Time Frame: 8, 12, and 24 hours after dosing in each period ]
    Number of Total Collisions

  4. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan [ Time Frame: Day 1: Predose through 48 hours postdose ]
    PK: Cmax of Lasmiditan

  5. PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan [ Time Frame: Day 1: Predose through 48 hours postdose ]
    PK: AUC of Lasmiditan



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined through medical history and physical examination.
  • Possess a valid driver's license and is an active driver at screening. Driven a minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.
  • Have a score of <10 on the Epworth Sleepiness Scale.

Exclusion Criteria:

  • Have a history within 3 months of admission, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
  • Have a history of difficulty either falling asleep or staying asleep in the previous 3 months of admission that is considered clinically significant by the investigator.
  • Are expected to use any other medication or dietary supplement to promote sleep including over the-counter sleep medications, during their participation in the study.
  • Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks prior to randomization.
  • Have worked in a night shift in the past 2 weeks prior to randomization.
  • Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
  • Show evidence of significant active neuropsychiatric disease (e.g., manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator.

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): NCT03459612


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance
Dallas, Texas, United States, 75247-4989
United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03459612     History of Changes
Other Study ID Numbers: 17048
H8H-MC-LAIF ( Other Identifier: Eli Lilly and Company )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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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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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents