- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Florida
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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
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
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:
|
Experimentell: 200 mg Lasmiditan
200 mg lasmiditan administered orally in one of four study periods.
|
Administreras oralt
Andra namn:
|
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
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Sensoriska systemagenter
- Bedövningsmedel
- Antiemetika
- Gastrointestinala medel
- Dermatologiska medel
- Serotoninmedel
- Serotoninreceptoragonister
- Hypnotika och lugnande medel
- Anestesimedel, lokal
- Anti-allergiska medel
- Sömnhjälpmedel, läkemedel
- Histamin H1-antagonister
- Histaminantagonister
- Histaminmedel
- Antiklåda
- Difenhydramin
- Prometazin
- Lasmiditan
Andra studie-ID-nummer
- 17048
- H8H-MC-LAIF (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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