Status:
COMPLETED
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2018
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03459612
Start Date
March 26 2018
End Date
June 23 2018
Last Update
January 13 2020
Active Locations (3)
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1
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
2
Covance
Dallas, Texas, United States, 75247-4989
3
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704