Clinical trial NCT03459612: A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Official title: A Phase I, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, 4-Period Cross-Over Study Assessing the Duration of Effect of Lasmiditan on Simulated Driving Performance in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 68
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
timeFrame: 8 hours postdose in each dosing period
measure: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
timeFrame: 12 hours postdose in each dose period
measure: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
timeFrame: 24 hours post dose in each dose period
Secondary outcomes:
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: 8 hours postdose in each dose period
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: 12 hours postdose in each dose period
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: 24 hours postdose in each dose period
measure: Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
timeFrame: 8 hours postdose in each dose period
measure: Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
timeFrame: 12 hours postdose in each dose period
measure: Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
timeFrame: 24 hours postdose in each dose period
measure: Total Number of Collisions
timeFrame: 8 hours postdose in each dose period
measure: Total Number of Collisions
timeFrame: 12 hours postdose in each dose period
measure: Total Number of Collisions
timeFrame: 24 hours postdose in each dose period
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
timeFrame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
timeFrame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
city: Dallas
country: United States
facility: Covance
state: Texas
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: