A Study of Lasmiditan on the Heart in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-16

Study Completion Date

2011-12-20

Brief Summary

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The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not 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

DOUBLE

Participants Investigators

Study Groups

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100 milligrams (mg) Lasmiditan

A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

100 mg administered orally (PO)

400 mg Lasmiditan

A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

400 mg administered PO

Placebo

Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered for lasmiditan or moxifloxacin

Moxifloxacin

A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

400 mg moxifloxacin administered PO

Interventions

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Lasmiditan

100 mg administered orally (PO)

Intervention Type DRUG

Lasmiditan

400 mg administered PO

Intervention Type DRUG

Placebo

Placebo administered for lasmiditan or moxifloxacin

Intervention Type DRUG

Moxifloxacin

400 mg moxifloxacin administered PO

Intervention Type DRUG

Other Intervention Names

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LY573144 LY573144

Eligibility Criteria

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Inclusion Criteria

* Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)
* In good physical and mental health as determined by the following:

* Complete medical history
* Complete physical examination
* Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
* Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
* Clinical laboratory tests

Exclusion Criteria

* Any of the following cardiac abnormalities on safety screening ECG:

* QTcF interval \>430 milliseconds (ms) for males, \>450 ms for females
* Unusual T wave morphology or flattened low voltage T waves
* PR interval \>240 ms or \<110 ms
* Second-degree or third-degree atrioventricular block
* ECG evidence of complete left or right bundle branch block
* Intraventricular conduction delay or QRS duration \>110 ms
* Supine resting heart rate \<45 beats per minute (bpm) or \>90 bpm
* Pathological Q-waves
* Evidence of ventricular pre-excitation
* Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
* Participants with a family history of Long QT syndrome
* History of allergic hypersensitivity to lasmiditan or any component of the formulations
* History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
* Participants with a history of postural hypotension or fainting
* Participant is not able to understand and comply with study requirements, instructions and study restrictions

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes