A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

Bioequivalence of Lasmiditan Oral Disintegrating Tablet Compared to Current Immediate-Release Tablet Formulation to Support Treatment of Migraine

The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas

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 overtly healthy as determined by medical evaluation.
• Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

• Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
• Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
• Have clinically significant abnormalities on ECG, as determined by investigator.
• Have a history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study interventions; or of interfering with the interpretation of data.
• Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 100 milligram (mg) Lasmiditan immediate release (IR) (Reference); Participants received 100 mg lasmiditan as IR tablet formulation administered orally.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: 100 mg Lasmiditan oral disintegrating (OD) Without Water (Test); Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: 100 mg Lasmiditan OD With Water (Test); Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan	PK: Cmax of Lasmiditan.	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Lasmiditan	PK: AUC[0-inf] of Lasmiditan.	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan	PK: AUC[0-tlast] of Lasmiditan.	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): July 24, 2021
• Study Completion (Actual): July 24, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 17016; H8H-MC-LAIA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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