The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants

• Status: Completed
• Trial end date: 2017-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CoLucid Pharmaceuticals; Eli Lilly and Company
• Collaborators: Algorithme Pharma Inc; Cognitive Research Corporation; CoLucid Pharmaceuticals
• Treatments: Alprazolam; Lasmiditan

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.