Healthy
Conditions
Brief summary
The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.
Interventions
DRUGLasmiditan
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation. * Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).
Exclusion criteria
* Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy. * Have an abnormal blood pressure and/or pulse rate, as determined by the investigator. * Have clinically significant abnormalities on ECG, as determined by investigator. * Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data. * Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose | PK: Cmax of Lasmiditan. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose | PK: AUC\[0-inf\] of Lasmiditan. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose | PK: AUC\[0-tlast\] of Lasmiditan. |
Countries
United States
Participant flow
Pre-assignment details
Crossover study with three study periods, each participant received immediate release (IR) tablet as reference; oral disintegrating (OD) tablet with water and without water as test doses of 100 milligram (mg) lasmiditan according to their assigned treatment sequence, on Day 1 of each Period. The washout period between dosing in consecutive study periods was approximately 5 days.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan OD with water. | 8 |
| Sequence 2 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan IR; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan OD without water. | 8 |
| Sequence 3 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan OD with water; and Period 3: 100 mg lasmiditan IR. | 8 |
| Sequence 4 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD without water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD with water. | 8 |
| Sequence 5 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan IR; and Period 3: 100 mg lasmiditan OD without water. | 8 |
| Sequence 6 Participants received lasmiditan on day 1 of each treatment period as per the below dosing sequence:
Period 1: 100 mg lasmiditan OD with water; Period 2: 100 mg lasmiditan OD without water; and Period 3: 100 mg lasmiditan IR. | 7 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 2 Washout | Adverse Event | 1 | 0 | 0 | 0 | 1 | 0 |
| Period 2 Washout | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Sequence 1 | Total | Sequence 6 | Sequence 5 | Sequence 4 | Sequence 3 | Sequence 2 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 13.3 | 40.4 years STANDARD_DEVIATION 12.8 | 47.3 years STANDARD_DEVIATION 12.5 | 43.5 years STANDARD_DEVIATION 11.5 | 35.8 years STANDARD_DEVIATION 12.6 | 40.6 years STANDARD_DEVIATION 14.3 | 35.6 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 10 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 37 Participants | 5 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 24 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 21 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 8 Participants | 47 Participants | 7 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 2 Participants | 16 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 31 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 46 | 0 / 44 |
| other Total, other adverse events | 0 / 47 | 0 / 46 | 0 / 44 |
| serious Total, serious adverse events | 0 / 47 | 0 / 46 | 0 / 44 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
PK: Cmax of Lasmiditan.
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Population: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan IR (Reference) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 140 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| 100 mg Lasmiditan OD Without Water (Test) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 123 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
| 100 mg Lasmiditan OD With Water (Test) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | 124 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
90% CI: [0.834, 0.919]
90% CI: [0.846, 0.934]
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan
PK: AUC\[0-inf\] of Lasmiditan.
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Population: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan IR (Reference) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | 937 nanogram*hour per milliliter (ng*h/ mL) | Geometric Coefficient of Variation 39 |
| 100 mg Lasmiditan OD Without Water (Test) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | 884 nanogram*hour per milliliter (ng*h/ mL) | Geometric Coefficient of Variation 39 |
| 100 mg Lasmiditan OD With Water (Test) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | 881 nanogram*hour per milliliter (ng*h/ mL) | Geometric Coefficient of Variation 39 |
90% CI: [0.914, 0.976]
90% CI: [0.914, 0.978]
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan
PK: AUC\[0-tlast\] of Lasmiditan.
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
Population: All enrolled participants who received at least one dose of study drug (lasmiditan) and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan IR (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | 915 ng*h/mL | Geometric Coefficient of Variation 39 |
| 100 mg Lasmiditan OD Without Water (Test) | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | 860 ng*h/mL | Geometric Coefficient of Variation 39 |
| 100 mg Lasmiditan OD With Water (Test) | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan | 860 ng*h/mL | Geometric Coefficient of Variation 39 |
90% CI: [0.91, 0.972]
90% CI: [0.913, 0.977]