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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lasmiditan

• Registration Number: NCT04881747
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Study Start: 2021-05-14
• Primary Completion: 2021-07-24
• Study Completion: 2021-07-24
• Status Verified: 2021-08
• Results First Submitted: 2022-06-09
• Results First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Results First Posted: 2023-03-23
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
100 mg Lasmiditan OD With Water (Test)	Lasmiditan	Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.
100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)	Lasmiditan	Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.
100 milligram (mg) Lasmiditan immediate release (IR) (Reference)	Lasmiditan	Participants received 100 mg lasmiditan as IR tablet formulation administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (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: Cmax of Lasmiditan.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (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: AUC\[0-inf\] of Lasmiditan.
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (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	PK: AUC\[0-tlast\] of Lasmiditan.

Trial Locations

Locations (1)

Covance Dallas; 🇺🇸 Dallas, Texas, United States