A Study of Multiple Doses of Lasmiditan in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lasmiditan; Drug: Placebo; Drug: Probe Drug Cocktail

Study type: Interventional

Funder types: Industry

Identifiers

NCT03252015

16859

H8H-MC-LAHE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating Lasmiditan, and have previously received Lasmiditan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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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70 participants in 5 patient groups, including a placebo group

Probe Drug Cocktail (Cohort 1a)

Experimental group

Description:

Probe Drug Cocktail administered orally on Day -3.

Treatment:

Drug: Probe Drug Cocktail

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

Experimental group

Description:

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

Treatment:

Drug: Probe Drug Cocktail

Drug: Lasmiditan

Placebo+Probe Drug Cocktail (Cohort 1b)

Placebo Comparator group

Description:

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

Treatment:

Drug: Probe Drug Cocktail

Drug: Placebo

400 mg Lasmiditan (Cohort 2a)

Experimental group

Description:

400 mg lasmiditan administered orally for 7 days.

Treatment:

Drug: Lasmiditan

Placebo (Cohort 2b)

Experimental group

Description:

Placebo administered orally for 7 days.

Treatment:

Drug: Placebo