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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881747
• Other study ID #: 17016
• Secondary ID: H8H-MC-LAIA
• Status: Completed
• Phase: Phase 1
• Start date: May 14, 2021
• Est. completion date: July 24, 2021

Study information

• Verified date: August 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 24, 2021
• Est. primary completion date: July 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lasmiditan
Administered orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas

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	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
Primary	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
Primary	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