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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan; Drug: Topiramate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Madison CRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lasmiditan Alone; Lasmiditan administered orally, alone	Drug: Lasmiditan; Administered orally; Other Names: LY573144
Placebo Comparator: Placebo Alone; Placebo administered orally, alone	Drug: Placebo; Administered orally
Experimental: Topiramate + Lasmiditan; Topiramate administered orally, alone, and co-administered with oral lasmiditan	Drug: Lasmiditan; Administered orally; Other Names: LY573144; Drug: Topiramate; Administered orally
Experimental: Topiramate + Placebo; Topiramate administered orally, alone, and co-administered with oral placebo	Drug: Placebo; Administered orally; Drug: Topiramate; Administered orally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14	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)
PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate 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: 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 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 From Zero to Infinity AUC(0-∞) 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 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): December 2, 2017
• Study Completion (Actual): December 2, 2017

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Anticonvulsants; Topiramate; Lasmiditan
• Other Study ID Numbers: 16925; H8H-MC-LAHT (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No