Status:
COMPLETED
A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03308669
Start Date
October 16 2017
End Date
December 2 2017
Last Update
November 27 2019
Active Locations (1)
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1
Covance Madison CRU
Madison, Wisconsin, United States, 53704