Healthy
Conditions
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.
Interventions
DRUGLasmiditan
Administered orally
DRUGPlacebo
Administered orally
DRUGDiphenhydramine
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 8 hours postdose in each dosing period | The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Karolinska Sleepiness Scale (KSS) Score | 8 hours postdose in each dose period | The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness. |
| Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 8 hours postdose in each dose period | The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed |
| Total Number of Collisions | 8 hours postdose in each dose period | Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event). |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose | PK: Cmax of Lasmiditan |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast) | Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose | PK: AUC of Lasmiditan until the last time a concentration is detected. |
Countries
United States
Participant flow
Pre-assignment details
Randomized, 4-period cross-over study in healthy participants.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration | 17 |
| Sequence 2 Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration | 17 |
| Sequence 3 Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration | 17 |
| Sequence 4 Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration | 17 |
| Total | 68 |
Baseline characteristics
| Characteristic | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 17 Participants | 17 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 6 Participants | 1 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 16 Participants | 11 Participants | 16 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 3 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 11 Participants | 12 Participants | 41 Participants |
| Region of Enrollment United States | 17 Participants | 17 Participants | 17 Participants | 17 Participants | 68 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 6 Participants | 10 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 11 Participants | 7 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 68 | 0 / 68 | 0 / 68 |
| other Total, other adverse events | 6 / 67 | 23 / 68 | 25 / 68 | 7 / 68 |
| serious Total, serious adverse events | 0 / 67 | 0 / 68 | 0 / 68 | 0 / 68 |
Outcome results
Primary
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)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Time frame: 8 hours postdose in each dosing period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 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) | 29.85 centimeters |
| 100 mg Lasmiditan | 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) | 30.83 centimeters |
| 200 mg Lasmiditan | 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) | 31.61 centimeters |
| 50 mg Diphenhydramine | 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) | 34.83 centimeters |
p-value: <0.000195% CI: [-0.43, 2.39]Mixed Models Analysis
p-value: <0.000195% CI: [0.32, 3.2]Mixed Models Analysis
p-value: <0.000195% CI: [3.58, 6.38]Mixed Models Analysis
Primary
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)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Time frame: 12 hours postdose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 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) | 30.41 centimeters |
| 100 mg Lasmiditan | 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) | 30.29 centimeters |
| 200 mg Lasmiditan | 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) | 30.09 centimeters |
| 50 mg Diphenhydramine | 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) | 34.72 centimeters |
p-value: <0.000195% CI: [-1.28, 1.04]Mixed Models Analysis
p-value: <0.000195% CI: [-1.51, 0.88]Mixed Models Analysis
p-value: <0.000195% CI: [3.17, 5.45]Mixed Models Analysis
Primary
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)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Time frame: 24 hours post dose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 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) | 32.04 centimeters |
| 100 mg Lasmiditan | 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) | 31.07 centimeters |
| 200 mg Lasmiditan | 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) | 31.00 centimeters |
| 50 mg Diphenhydramine | 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) | 36.10 centimeters |
p-value: <0.000195% CI: [-2.3, 0.36]Mixed Models Analysis
p-value: <0.000195% CI: [-2.4, 0.32]Mixed Models Analysis
p-value: <0.000195% CI: [2.73, 5.38]Mixed Models Analysis
Secondary
Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Time frame: 24 hours postdose in each dose period
Population: All randomized participants that received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Karolinska Sleepiness Scale (KSS) Score | 4.19 units on a scale | Standard Deviation 2.02 |
| 100 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.72 units on a scale | Standard Deviation 1.69 |
| 200 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.93 units on a scale | Standard Deviation 2.13 |
| 50 mg Diphenhydramine | Karolinska Sleepiness Scale (KSS) Score | 4.75 units on a scale | Standard Deviation 2.15 |
95% CI: [-1.1, -0.06]
95% CI: [-0.89, 0.09]
95% CI: [-0.09, 0.96]
Secondary
Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Time frame: 8 hours postdose in each dose period
Population: All randomized participant that received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Karolinska Sleepiness Scale (KSS) Score | 3.19 Units on a scale | Standard Deviation 1.61 |
| 100 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.46 Units on a scale | Standard Deviation 1.65 |
| 200 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.90 Units on a scale | Standard Deviation 1.78 |
| 50 mg Diphenhydramine | Karolinska Sleepiness Scale (KSS) Score | 3.93 Units on a scale | Standard Deviation 1.76 |
95% CI: [-0.15, 0.7]
95% CI: [0.22, 1.1]
95% CI: [0.39, 1.24]
Secondary
Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Time frame: 12 hours postdose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Karolinska Sleepiness Scale (KSS) Score | 3.43 units on a scale | Standard Deviation 1.57 |
| 100 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.94 units on a scale | Standard Deviation 1.62 |
| 200 mg Lasmiditan | Karolinska Sleepiness Scale (KSS) Score | 3.79 units on a scale | Standard Deviation 1.74 |
| 50 mg Diphenhydramine | Karolinska Sleepiness Scale (KSS) Score | 4.74 units on a scale | Standard Deviation 2.05 |
95% CI: [0, 0.96]
95% CI: [-0.14, 0.82]
95% CI: [0.81, 1.78]
Secondary
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
Time frame: 12 hours postdose in each dose period
Population: All randomized participants who received study drug and have evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 71.33 Correct responses | Standard Deviation 11.26 |
| 100 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 70.91 Correct responses | Standard Deviation 9.87 |
| 200 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 72.16 Correct responses | Standard Deviation 9.91 |
| 50 mg Diphenhydramine | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 68.21 Correct responses | Standard Deviation 10.04 |
95% CI: [-3.52, -0.06]
95% CI: [-2, 1.42]
95% CI: [-5.53, -2.08]
Secondary
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed
Time frame: 8 hours postdose in each dose period
Population: All randomized participant that received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 69.48 Correct responses | Standard Deviation 11.32 |
| 100 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 69.76 Correct responses | Standard Deviation 10.17 |
| 200 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 68.88 Correct responses | Standard Deviation 11.27 |
| 50 mg Diphenhydramine | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 69.01 Correct responses | Standard Deviation 11.21 |
95% CI: [-1.61, 1.62]
95% CI: [-2.49, 1.01]
95% CI: [-2.32, 0.89]
Secondary
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
Time frame: 24 hours postdose in each dose period
Population: All randomized participants who received study drug and have evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 70.78 Correct responses | Standard Deviation 9.84 |
| 100 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 70.53 Correct responses | Standard Deviation 10.52 |
| 200 mg Lasmiditan | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 70.66 Correct responses | Standard Deviation 10.24 |
| 50 mg Diphenhydramine | Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test | 68.31 Correct responses | Standard Deviation 10.27 |
95% CI: [-1.71, 1.15]
95% CI: [-1.71, 1.08]
95% CI: [-4.13, -1.27]
Secondary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
PK: Cmax of Lasmiditan
Time frame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 183 nanograms per milliliter | Geometric Coefficient of Variation 31 |
| 100 mg Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 366 nanograms per milliliter | Geometric Coefficient of Variation 30 |
Secondary
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
PK: AUC of Lasmiditan until the last time a concentration is detected.
Time frame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast) | 1060 ng*hour per milliliter | Geometric Coefficient of Variation 28 |
| 100 mg Lasmiditan | PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast) | 2230 ng*hour per milliliter | Geometric Coefficient of Variation 25 |
Secondary
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Time frame: 8 hours postdose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Number of Collisions | 0.1 collisions | Standard Deviation 0.2 |
| 100 mg Lasmiditan | Total Number of Collisions | 0.0 collisions | Standard Deviation 0.2 |
| 200 mg Lasmiditan | Total Number of Collisions | 0.0 collisions | Standard Deviation 0.1 |
| 50 mg Diphenhydramine | Total Number of Collisions | 0.4 collisions | Standard Deviation 1.1 |
p-value: 0.6875Wilcoxon Signed Rank test
p-value: 0.375Wilcoxon Signed Rank test
p-value: 0.0115Wilcoxon Signed Rank test
Secondary
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Time frame: 12 hours postdose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Number of Collisions | 0.1 collisions | Standard Deviation 0.4 |
| 100 mg Lasmiditan | Total Number of Collisions | 0.0 collisions | Standard Deviation 0.1 |
| 200 mg Lasmiditan | Total Number of Collisions | 0.1 collisions | Standard Deviation 0.3 |
| 50 mg Diphenhydramine | Total Number of Collisions | 0.2 collisions | Standard Deviation 0.7 |
p-value: 0.1563Wilcoxon Signed Rank test
p-value: 0.5938Wilcoxon Signed Rank test
p-value: 0.0938Wilcoxon Signed Rank test
Secondary
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Time frame: 24 hours postdose in each dose period
Population: All randomized participants who received at least 1 dose of study drug and had evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Number of Collisions | 0.2 collisions | Standard Deviation 0.6 |
| 100 mg Lasmiditan | Total Number of Collisions | 0.0 collisions | Standard Deviation 0.2 |
| 200 mg Lasmiditan | Total Number of Collisions | 0.2 collisions | Standard Deviation 0.7 |
| 50 mg Diphenhydramine | Total Number of Collisions | 0.6 collisions | Standard Deviation 1.7 |
p-value: 0.125Wilcoxon Signed Rank test
p-value: 0.959Wilcoxon Signed Rank test
p-value: 0.0097Wilcoxon Signed Rank test