The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design with 5-period (full) crossover study with participants randomized to treatment sequences. Participants will complete all 5 Periods.
During each Period, participants will come to the clinical research unit (CRU) and remain overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo in the morning. Cognitive testing and driving simulation will be conducted post dosing. Participants will have a washout of at least 5 days between each Period.
This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect treatment effects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Able and willing to voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
- Males and females between the ages of 21 and 50 years of age (inclusive). No more than 60% of one gender will be enrolled in the study.
- Body Mass Index (BMI) between 18 and 32 kilograms per meter squared (kg/m²) (inclusive).
- Participant is able to reliably perform study assessments (Standard Deviation of Lateral Position (SDLP) no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario; Symbol Digit Coding (SDC) Correct no less than 1 standard deviation below the mean for healthy adults in their age range); demonstrates the ability to understand task instructions, and is physically capable (e.g., adequate manual dexterity, vision, and hearing) and cognitively capable of performing study tasks.
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years.
- Participant must also demonstrate simulator sickness questionnaire scores which are not indicative of simulator sickness as defined in the driving simulation operations manual.
- 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).
- Participant has a score < 10 on the Epworth Sleepiness Scale.
- Use of a medically highly effective form of birth control during the study and for thirty (30) days:
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
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History or presence of clinically significant condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
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A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
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A history of difficulty either falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator.
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Participant has a history or diagnosis of any of the following conditions:
- Primary or secondary insomnia
- Narcolepsy
- Cataplexy (familial or idiopathic)
- Circadian Rhythm Sleep Disorder
- Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement behavior disorder
- Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome)
- Periodic Limb Movement Disorder
- Restless Legs Syndrome
- Primary Hypersomnia
- Excessive Daytime Sleepiness (EDS)
- Participant has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
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Expected to use any other medication or dietary supplement to promote sleep including over- the-counter sleep medications, during their participation in the study.
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Participant consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages per day.
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Participant has traveled across 1 or more time zones (transmeridian travel) in the last 2 weeks prior to randomization or is expected to travel across 1 or more time zones during the study.
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Expected to work on a rotating shift during their participation in the study.
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Participant works a night shift.
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History or presence of seizure disorder.
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History of urinary retention, angle closure glaucoma, or increased ocular pressure.
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History of gastrointestinal tract surgery, except for appendectomy.
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Has abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
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Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities
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History of orthostatic hypotension, fainting spells, or blackouts, that are considered clinically significant by the investigator.
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The presence of chronic or acute infections, that are considered clinically significant by the investigator.
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History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the study as judged by the Investigator.
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Use of psychoactive prescription or non-prescription medications, psychoactive nutritional supplements or herbal preparations within 2 weeks or 5 half-lives (whichever is longer) of admission to the clinical research unit (CRU) on Day -1.
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Has received any previous study drug within 30 days prior to the first dose of this study drug.
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Is a smoker of more than 10 cigarettes or eCigarettes, or 3 cigars or 3 pipes per day, and is unable to refrain from smoking while confined to the CRU.
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Has any history of dependency or treatment for substance abuse within the past 2 years.
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Participant with a history of alcoholism or who consumes excessive amounts of alcohol.
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Participants who consume alcohol on a regular basis (i.e., ≥ 5 times/week) before bedtime will be excluded from the study.
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Inability to comply with the dietary regimen of the clinical research center.
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Pregnancy / positive pregnancy test.
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Planning to become pregnant during the study or within 1 month of study completion.
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Inability to use adequate contraception during the study. It is recommended that adequate contraception be used for 30 days following completion of the study.
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Has a positive screen for alcohol or other drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
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Has a history for Hepatitis B, Hepatitis C , or Human Immunodeficiency Virus (HIV) at Screening or has been previously treated for Hepatitis B, Hepatitis C, or HIV.
Trial design
Primary purpose
Allocation
Interventional model
Masking
90 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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