the effects of lasmiditan on simulated driving performance - healthy participants

Conditions: Migraine

Summary: 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.


Eligibility criteria:
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: * 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. * 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. * a history of difficulty either falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator. * 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. * expected to use any other medication or dietary supplement to promote sleep including over- the-counter sleep medications, during their participation in the study. * participant consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages per day. * 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. * expected to work on a rotating shift during their participation in the study. * participant works a night shift. * history or presence of seizure disorder. * history of urinary retention, angle closure glaucoma, or increased ocular pressure. * history of gastrointestinal tract surgery, except for appendectomy. * 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. * presence of out-of-range cardiac interval on the screening ecg or other clinically significant ecg abnormalities * history of orthostatic hypotension, fainting spells, or blackouts, that are considered clinically significant by the investigator. * the presence of chronic or acute infections, that are considered clinically significant by the investigator. * history of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the study as judged by the investigator. * 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. * has received any previous study drug within 30 days prior to the first dose of this study drug. * 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. * has any history of dependency or treatment for substance abuse within the past 2 years. * participant with a history of alcoholism or who consumes excessive amounts of alcohol. * participants who consume alcohol on a regular basis (i.e., ≥ 5 times/week) before bedtime will be excluded from the study. * inability to comply with the dietary regimen of the clinical research center. * pregnancy / positive pregnancy test. * planning to become pregnant during the study or within 1 month of study completion. * inability to use adequate contraception during the study. it is recommended that adequate contraception be used for 30 days following completion of the study. * has a positive screen for alcohol or other drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates). * 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.