A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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Bioequivalence of Lasmiditan Oral Disintegrating Tablet Compared to Current Immediate-Release Tablet Formulation to Support Treatment of Migraine

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lasmiditan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100 milligram (mg) Lasmiditan immediate release (IR) (Reference)<br>Participants received 100 mg lasmiditan as IR tablet formulation administered orally. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|
| Experimental: 100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)<br>Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|
| Experimental: 100 mg Lasmiditan OD With Water (Test)<br>Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water. | Drug: Lasmiditan<br>* Administered orally.<br>* Other names: LY573144;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan | PK: 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: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan | PK: 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: 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. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose |