Healthy
Conditions
Brief summary
The purpose of this study is to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it by comparing the results of healthy elderly participants to those of healthy young participants. The tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. This study will last up to approximately 19 days, not including screening. This study requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four days/three nights. Participants will return for a follow-up seven days after last dose of study drug. Screening is required within 28 days prior to Day 1. This study is for research purposes only and is not intended to treat any medical condition.
Interventions
DRUGLasmiditan
Oral administration
DRUGPlacebo
Oral administration
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination. * Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening.
Exclusion criteria
* Have known allergies to lasmiditan, related compounds or any components of the formulation. * Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study. * Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m². * Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C. * Are women with a positive pregnancy test or women who are lactating. * Have a clinically significant abnormality in the neurological examination. * Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator. * Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours | Maximum Observed Drug Concentration (Cmax) of Lasmiditan. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours | Area under the concentration versus time curve from zero to infinity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Elderly Placebo on Day 1 of 1 of 2 dosing periods or 200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods. | 18 |
| 200 mg Lasmiditan (Group 2 Young) 200 mg of lasmiditan on Day 1. | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Group 1 Elderly | Total | 200 mg Lasmiditan (Group 2 Young) |
|---|---|---|---|
| Age, Continuous | 70.6 years STANDARD_DEVIATION 5.4 | 51.5 years STANDARD_DEVIATION 21 | 31.3 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 30 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 34 Participants | 17 Participants |
| Region of Enrollment United States | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 3 / 18 | 8 / 18 | 8 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 17 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan
Area under the concentration versus time curve from zero to infinity
Time frame: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Lasmiditan (Group 1 Elderly) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | 2480 Nanograms*hour per Millilitre (ng.h/mL) | Geometric Coefficient of Variation 44 |
| 200 mg Lasmiditan (Group 2 Young) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan | 1970 Nanograms*hour per Millilitre (ng.h/mL) | Geometric Coefficient of Variation 30 |
90% CI: [1.03, 1.55]
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Time frame: Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Lasmiditan (Group 1 Elderly) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 368 Nanograms Per Millilitre (ng/mL) | Geometric Coefficient of Variation 43 |
| 200 mg Lasmiditan (Group 2 Young) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 304 Nanograms Per Millilitre (ng/mL) | Geometric Coefficient of Variation 40 |
90% CI: [0.962, 1.52]