A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2018-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo administered orally in one of four study periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

100 milligrams (mg) Lasmiditan

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally

200 mg Lasmiditan

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally

Diphenhydramine

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

Group Type ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type DRUG

Administered orally

Interventions

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Lasmiditan

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Diphenhydramine

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY573144

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes