A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan; Drug: Diphenhydramine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03459612

17048

H8H-MC-LAIF (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research unit. Screening must be completed within 28 days before the start of the study. Follow-up will be completed about one week after discharge.

Enrollment: 68 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administered orally in one of four study periods.

Treatment:

Drug: Placebo

100 milligrams (mg) Lasmiditan

Experimental group

Description:

100 mg lasmiditan administered orally in one of four study periods.

Treatment:

Drug: Lasmiditan

200 mg Lasmiditan

Experimental group

Description:

200 mg lasmiditan administered orally in one of four study periods.

Treatment:

Drug: Lasmiditan

Diphenhydramine

Active Comparator group

Description:

50 mg diphenhydramine administered orally in one of four study periods.

Treatment:

Drug: Diphenhydramine