A Study of Lasmiditan in Healthy Japanese and Caucasian 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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-27

Study Completion Date

2018-08-09

Brief Summary

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

The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.

Related Clinical Trials

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

A Study of Lasmiditan in Healthy Chinese Participants

NCT04081324

Healthy

COMPLETED PHASE1

A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

NCT04586920

Healthy

TERMINATED PHASE1

Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects

NCT05387668

Healthy Volunteers

WITHDRAWN PHASE1

A Study of LY3473329 in Healthy Japanese Participants

NCT05038787

Healthy

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

NCT05806359

Healthy Volunteers

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

CROSSOVER

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.

Lasmiditan - Japanese

Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally.

Placebo - Japanese

Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Lasmiditan - Caucasian

Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.

Group Type EXPERIMENTAL

Lasmiditan

Intervention Type DRUG

Administered orally.

Placebo - Caucasian

Single dose of Placebo administered orally in up to one of three study periods.

Group Type PLACEBO_COMPARATOR

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.

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

* Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria

* Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
* Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
* Have an abnormal supine blood pressure at screening.
* Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of \>20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of \>10 mmHg at screening.
* Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
* Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes