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A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

27 december 2019 uppdaterad av: Eli Lilly and Company

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

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

68

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Florida
      • Daytona Beach, Florida, Förenta staterna, 32117
        • Covance Clinical Research Inc
    • Texas
      • Dallas, Texas, Förenta staterna, 75247-4989
        • Covance
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53704
        • Covance Clinical Research Inc

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år till 50 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Placebo administrerat oralt i en av fyra studieperioder.
Administreras oralt
Experimentell: 100 milligrams (mg) Lasmiditan
100 mg lasmiditan administered orally in one of four study periods.
Administreras oralt
Andra namn:
  • LY573144
Experimentell: 200 mg Lasmiditan
200 mg lasmiditan administered orally in one of four study periods.
Administreras oralt
Andra namn:
  • LY573144
Aktiv komparator: Diphenhydramine
50 mg diphenhydramine administered orally in one of four study periods.
Administered orally

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Tidsram: 8 hours postdose in each dosing period

The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.

LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.

8 hours postdose in each dosing period
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Tidsram: 12 hours postdose in each dose period

The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.

LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.

12 hours postdose in each dose period
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Tidsram: 24 hours post dose in each dose period

The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.

LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.

24 hours post dose in each dose period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Karolinska Sleepiness Scale (KSS) Score
Tidsram: 8 hours postdose in each dose period
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
8 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
Tidsram: 12 hours postdose in each dose period
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
12 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
Tidsram: 24 hours postdose in each dose period
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
24 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Tidsram: 8 hours postdose in each dose period
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed
8 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Tidsram: 12 hours postdose in each dose period
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
12 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Tidsram: 24 hours postdose in each dose period
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
24 hours postdose in each dose period
Total Number of Collisions
Tidsram: 8 hours postdose in each dose period
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
8 hours postdose in each dose period
Total Number of Collisions
Tidsram: 12 hours postdose in each dose period
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
12 hours postdose in each dose period
Total Number of Collisions
Tidsram: 24 hours postdose in each dose period
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
24 hours postdose in each dose period
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Tidsram: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
PK: Cmax of Lasmiditan
Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
Tidsram: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
PK: AUC of Lasmiditan until the last time a concentration is detected.
Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 mars 2018

Primärt slutförande (Faktisk)

23 juni 2018

Avslutad studie (Faktisk)

23 juni 2018

Studieregistreringsdatum

Först inskickad

2 mars 2018

Först inskickad som uppfyllde QC-kriterierna

7 mars 2018

Första postat (Faktisk)

9 mars 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 december 2019

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Tidsram för IPD-delning

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Kriterier för IPD Sharing Access

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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