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

NCT03308669 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16925H8H-MC-LAHT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  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

  Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours

Study Arms (4)

Lasmiditan Alone

EXPERIMENTAL

Lasmiditan administered orally, alone

Drug: Lasmiditan

Placebo Alone

PLACEBO COMPARATOR

Placebo administered orally, alone

Drug: Placebo

Topiramate + Lasmiditan

EXPERIMENTAL

Topiramate administered orally, alone, and co-administered with oral lasmiditan

Drug: Lasmiditan; Drug: Topiramate

Topiramate + Placebo

EXPERIMENTAL

Topiramate administered orally, alone, and co-administered with oral placebo

Drug: Placebo; Drug: Topiramate

Interventions

Lasmiditan DRUG

Administered orally

Also known as: LY573144

Lasmiditan Alone; Topiramate + Lasmiditan

Placebo DRUG

Administered orally

Placebo Alone; Topiramate + Placebo

Topiramate DRUG

Administered orally

Topiramate + Lasmiditan; Topiramate + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Madison CRU

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

lasmiditan; Topiramate

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: October 16, 2017
• Primary Completion: December 2, 2017
• Study Completion: December 2, 2017
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2018-01

Locations

US (1)