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

• Status: Completed
• Trial end date: 2017-12-02
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Lasmiditan; Topiramate

Criteria

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