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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2017-12-02

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Administered orally

Interventions

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Lasmiditan

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Topiramate

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY573144

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes