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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Topiramate; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03308669

16925

H8H-MC-LAHT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

Lasmiditan Alone

Experimental group

Description:

Lasmiditan administered orally, alone

Treatment:

Drug: Lasmiditan

Placebo Alone

Placebo Comparator group

Description:

Placebo administered orally, alone

Treatment:

Drug: Placebo

Topiramate + Lasmiditan

Experimental group

Description:

Topiramate administered orally, alone, and co-administered with oral lasmiditan

Treatment:

Drug: Lasmiditan

Drug: Topiramate

Topiramate + Placebo

Experimental group

Description:

Topiramate administered orally, alone, and co-administered with oral placebo

Treatment:

Drug: Placebo

Drug: Topiramate