A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

Study Overview
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Brief Summary
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This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected. Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14. This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.

Official Title
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Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lasmiditan
* Drug: Placebo
* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are healthy males or females (of non-child bearing potential), as determined by medical history and physical examination Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive Exclusion Criteria: Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate Have an abnormal supine blood pressure, defined as systolic blood pressure less than (<) 90 or great (>) 140 millimeters of mercury (mmHg) or diastolic blood pressure <60 or >90 mmHg at screening Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) Have a clinically significant abnormality in the neurological examination Have current or a history of orthostatic hypotension (>20-mmHg drop in systolic blood pressure, or >10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing Have an estimated glomerular filtration rate using Modification of Diet in Renal Disease <60 milliliter per minute (mL/min) per 1.73 meter squared (m²) Have a history of glaucoma Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasmiditan Alone<br>Lasmiditan administered orally, alone | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;|
| Placebo Comparator: Placebo Alone<br>Placebo administered orally, alone | Drug: Placebo<br>* Administered orally<br>|
| Experimental: Topiramate + Lasmiditan<br>Topiramate administered orally, alone, and co-administered with oral lasmiditan | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Topiramate<br>* Administered orally<br>|
| Experimental: Topiramate + Placebo<br>Topiramate administered orally, alone, and co-administered with oral placebo | Drug: Placebo<br>* Administered orally<br>Drug: Topiramate<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline through Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14 | Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) | 
| PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours | 
| PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC [tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14 | Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h) | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14 | Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours |