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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04881747

17016

H8H-MC-LAIA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

100 milligram (mg) Lasmiditan immediate release (IR) (Reference)

Active Comparator group

Description:

Participants received 100 mg lasmiditan as IR tablet formulation administered orally.

Treatment:

Drug: Lasmiditan

100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)

Experimental group

Description:

Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.

Treatment:

Drug: Lasmiditan

100 mg Lasmiditan OD With Water (Test)

Experimental group

Description:

Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.

Treatment:

Drug: Lasmiditan