Phase 1 Completed N=30 Randomized Double-blind Basic Science

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

Healthy

Source: ClinicalTrials.gov NCT03308669 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	4300; 4190	—
SECONDARY PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14	276; 301	—
SECONDARY PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	42600; 42800	—
SECONDARY PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14	1860; 2050	—

Eligibility 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 ( ) 140 millimeters of mercury (mmHg) or diastolic blood pressure 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03308669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.