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

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Lasmiditan When Co-administered With Topiramate in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308669
• Other study ID #: 16925
• Secondary ID: H8H-MC-LAHT
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2017
• Est. completion date: December 2, 2017

Study information

• Verified date: January 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2, 2017
• Est. primary completion date: December 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lasmiditan
Administered orally
• Placebo
Administered orally
• Topiramate
Administered orally

Locations

Country	Name	City	State
United States	Covance Madison CRU	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
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	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)
Secondary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-8) 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(0-8) 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