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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Lasmiditan
Drug: Topiramate

Registration Number: NCT03308669

Lead Sponsor: Eli Lilly and Company

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Alone	Placebo	Placebo administered orally, alone
Topiramate + Lasmiditan	Lasmiditan	Topiramate administered orally, alone, and co-administered with oral lasmiditan
Topiramate + Placebo	Placebo	Topiramate administered orally, alone, and co-administered with oral placebo
Topiramate + Lasmiditan	Topiramate	Topiramate administered orally, alone, and co-administered with oral lasmiditan
Topiramate + Placebo	Topiramate	Topiramate administered orally, alone, and co-administered with oral placebo
Lasmiditan Alone	Lasmiditan	Lasmiditan administered orally, alone

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 24	A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14	Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours	PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14
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	Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)	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
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	Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours	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