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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2021-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Lasmiditan

Intervention Type DRUG

Administered orally.

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

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally.

100 mg Lasmiditan OD With Water (Test)

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

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally.

Interventions

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Lasmiditan

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY573144

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes