- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT03459612
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Florida
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Daytona Beach, Florida, Egyesült Államok, 32117
- Covance Clinical Research Inc
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Texas
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Dallas, Texas, Egyesült Államok, 75247-4989
- Covance
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Wisconsin
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Madison, Wisconsin, Egyesült Államok, 53704
- Covance Clinical Research Inc
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Placebo Comparator: Placebo
Placebo orálisan adva a négy vizsgálati időszak egyikében.
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Orálisan beadva
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Kísérleti: 100 milligrams (mg) Lasmiditan
100 mg lasmiditan administered orally in one of four study periods.
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Orálisan beadva
Más nevek:
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Kísérleti: 200 mg Lasmiditan
200 mg lasmiditan administered orally in one of four study periods.
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Orálisan beadva
Más nevek:
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Aktív összehasonlító: Diphenhydramine
50 mg diphenhydramine administered orally in one of four study periods.
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Administered orally
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
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)
Időkeret: 8 hours postdose in each dosing period
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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
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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)
Időkeret: 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
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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)
Időkeret: 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
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Karolinska Sleepiness Scale (KSS) Score
Időkeret: 8 hours postdose in each dose period
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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.
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8 hours postdose in each dose period
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Karolinska Sleepiness Scale (KSS) Score
Időkeret: 12 hours postdose in each dose period
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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.
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12 hours postdose in each dose period
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Karolinska Sleepiness Scale (KSS) Score
Időkeret: 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.
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24 hours postdose in each dose period
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Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Időkeret: 8 hours postdose in each dose period
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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
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8 hours postdose in each dose period
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Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Időkeret: 12 hours postdose in each dose period
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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.
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12 hours postdose in each dose period
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Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Időkeret: 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
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Total Number of Collisions
Időkeret: 8 hours postdose in each dose period
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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).
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8 hours postdose in each dose period
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Total Number of Collisions
Időkeret: 12 hours postdose in each dose period
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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).
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12 hours postdose in each dose period
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Total Number of Collisions
Időkeret: 24 hours postdose in each dose period
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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).
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24 hours postdose in each dose period
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Időkeret: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
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PK: Cmax of Lasmiditan
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Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
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PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
Időkeret: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
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PK: AUC of Lasmiditan until the last time a concentration is detected.
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Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- A gyógyszerek élettani hatásai
- Neurotranszmitter szerek
- A farmakológiai hatás molekuláris mechanizmusai
- Központi idegrendszer depresszánsai
- Autonóm ügynökök
- Perifériás idegrendszeri szerek
- Érzékszervi rendszer ügynökei
- Anesztetikumok
- Hányáscsillapítók
- Gasztrointesztinális szerek
- Bőrgyógyászati szerek
- Szerotonin szerek
- Szerotonin receptor agonisták
- Altatók és nyugtatók
- Helyi érzéstelenítők
- Antiallergén szerek
- Alvássegítők, Gyógyszerészeti
- Hisztamin H1 antagonisták
- Hisztamin antagonisták
- Hisztamin szerek
- Viszketés elleni szerek
- Difenhidramin
- Prometazin
- Lasmiditan
Egyéb vizsgálati azonosító számok
- 17048
- H8H-MC-LAIF (Egyéb azonosító: Eli Lilly and Company)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
IPD megosztási időkeret
IPD-megosztási hozzáférési feltételek
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- CSR
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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