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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/1/2018
Start Date:October 16, 2017
End Date:December 2, 2017

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

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.


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
We found this trial at
1
site
3402 Kinsman Boulevard
Madison, Wisconsin 53704
Principal Investigator: Nicholas Siebers, MD
Phone: 866-429-3700
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mi
from
Madison, WI
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