Healthy
Conditions
Brief summary
This is a study of lasmiditan in healthy Chinese participants. The purposes are: * To evaluate the safety of lasmiditan * To learn more about how the body processes lasmiditan The study will last up to 50 days for each participant.
Interventions
DRUGLasmiditan
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin) males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive * Are able and willing to give signed informed consent
Exclusion criteria
* Have known allergies to lasmiditan, related compounds or any components of the formulation * Have an abnormal blood pressure and/or pulse rate as determined clinically significant by the investigator * Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression) * Have a history of central nervous system (CNS) conditions such as strokes, transient ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study * Regularly use known drugs of abuse and/or show positive findings on drug screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose | PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1). |
| PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) | PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10). |
| PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10). |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose) | PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo administered orally on Day 1 and repeated doses on Days 4 to 10 (7 days of dosing). | 6 |
| 50 mg Lasmiditan Participants received 50 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 50 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 10 |
| 100 mg Lasmiditan Participants received 100 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 100 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 10 |
| 200 mg Lasmiditan Participants received 200 mg lasmiditan administered orally once on the morning of Day 1 after an overnight fast of at least 8 hours. Following a period of at least 72 hours without dosing, participants received multiple once-daily oral doses of 200 mg lasmiditan on Days 4 to 10 (7 days of dosing) after overnight fasts of at least 8 hours prior to each dose. | 10 |
| Total | 36 |
Baseline characteristics
| Characteristic | Placebo | Total | 200 mg Lasmiditan | 100 mg Lasmiditan | 50 mg Lasmiditan |
|---|---|---|---|---|---|
| Age, Continuous | 31.20 years STANDARD_DEVIATION 9.75 | 31.70 years STANDARD_DEVIATION 6.19 | 30.00 years STANDARD_DEVIATION 5.66 | 33.40 years STANDARD_DEVIATION 4.88 | 31.90 years STANDARD_DEVIATION 5.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 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 | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 3 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 27 Participants | 7 Participants | 9 Participants | 7 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 / 6 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 5 / 6 | 9 / 10 | 10 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 6 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan
PK: Area Under the Concentration Versus Time Curve from time zero to infinity AUC(0-∞) of Lasmiditan after single dose (Day 1).
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 50 mg Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | 385 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 48 |
| 100 mg Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | 829 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 34 |
| 200 mg Lasmiditan | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-∞) of Lasmiditan | 1990 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 34 |
Primary
PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan
PK: AUCτ of of Lasmiditan was calculated based on the of Lasmiditan plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau \[τ\]) when Lasmiditan was administered after single dose (day 1) and multiple doses (Day 10).
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 1 | 378 ng*h/mL | Geometric Coefficient of Variation 47 |
| 50 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 10 | 429 ng*h/mL | Geometric Coefficient of Variation 36 |
| 100 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 1 | 809 ng*h/mL | Geometric Coefficient of Variation 34 |
| 100 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 10 | 898 ng*h/mL | Geometric Coefficient of Variation 28 |
| 200 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 1 | 1950 ng*h/mL | Geometric Coefficient of Variation 34 |
| 200 mg Lasmiditan | PK: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of of Lasmiditan | Day 10 | 2140 ng*h/mL | Geometric Coefficient of Variation 33 |
Primary
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan after single dose (day 1) and multiple doses (Day 10).
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 50 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1 | 69.6 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 48 |
| 50 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 10 | 78.8 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| 100 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1 | 154 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| 100 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 10 | 187 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 28 |
| 200 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 1 | 359 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 33 |
| 200 mg Lasmiditan | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan | Day 10 | 394 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
Primary
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan
PK: Time to Maximum Observed Plasma Concentration (tmax) of Lasmiditan after single dose (Day 1) and multiple doses (Day 10).
Time frame: Day 1 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, and 24 hours post-dose) and Day 10 (Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose)
Population: All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 50 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 1 | 1.50 hours (h) |
| 50 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 10 | 1.75 hours (h) |
| 100 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 1 | 1.50 hours (h) |
| 100 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 10 | 1.50 hours (h) |
| 200 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 1 | 1.50 hours (h) |
| 200 mg Lasmiditan | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Lasmiditan | Day 10 | 1.50 hours (h) |