A Study of Multiple Doses of Lasmiditan in Healthy Participants

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood stream and how long it takes the body to get rid of it.

When drugs are taken together, one or all of the drugs used in combination may be affected. This study will also evaluate the concentrations in the blood of a probe drug cocktail taken alone and in combination with lasmiditan. Information about any side effects that may occur will also be collected.

The study has two parts. Participants will only enroll in one part. This study will last about 25 days for group 1 and 22 days for group 2, not including screening. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects

NCT04793295

Healthy Subjects

COMPLETED PHASE1

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

NCT02195635

Drug Interactions

COMPLETED PHASE1

A Drug Interaction Study of LY3871801 in Healthy Participants

NCT05602675

Healthy

COMPLETED PHASE1

Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

NCT05872958

COVID-19

COMPLETED PHASE1

Drug Interaction Study Between AZD3480 and Cytochrome P450

NCT00692510

Metabolism Alzheimer's Disease

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probe Drug Cocktail (Cohort 1a)

Probe Drug Cocktail administered orally on Day -3.

Group Type EXPERIMENTAL

Probe Drug Cocktail

Intervention Type DRUG

Administered orally

200 milligrams (mg) Lasmiditan+Probe Drug Cocktail (Cohort 1)

200 mg lasmiditan administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.

Group Type EXPERIMENTAL

Probe Drug Cocktail

Intervention Type DRUG

Administered orally

Lasmiditan

Intervention Type DRUG

Administered orally

Placebo+Probe Drug Cocktail (Cohort 1b)

Placebo administered alone, orally, on Days 1-6 and concurrently with probe drug cocktail on Day 7.

Group Type PLACEBO_COMPARATOR

Probe Drug Cocktail

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

400 mg Lasmiditan (Cohort 2a)

400 mg lasmiditan administered orally for 7 days.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally

Placebo (Cohort 2b)

Placebo administered orally for 7 days.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probe Drug Cocktail

Administered orally

Intervention Type DRUG

Lasmiditan

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY573144

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria

* Have participated, within the last 30 days, in a clinical study involving an Investigational Product (IP)
* Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan
* Have clinically significant abnormality in the 12-lead ECG, including corrected QT interval (QTc) with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds (ms) for men or \>470 ms for women or any abnormality that in the opinion of the investigator increases the risk of participating in the study (not limited to significant bradycardia or heart block)
* History of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression), have a recent history of a suicide attempt (30 days within screening visit and any time between screening visit and baseline); or are clinically judged by the investigator to be at risk for suicide
* History of hypoglycemia
* Known history of glucose-6-phosphate dehydrogenase deficiency
* Are taking a concomitant medication or a dietary substance that affects cytochrome P450 (CYP)1A2, CYP2C9, and/or CYP3A isotypes within 14 days of screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes