A Study of Lasmiditan in Healthy Participants

Healthy Clinical Trial

Official title:

Effect of Age on the Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182920
• Other study ID #: 16852
• Secondary ID: H8H-MC-LAHA
• Status: Completed
• Phase: Phase 1
• Start date: June 16, 2017
• Est. completion date: August 14, 2017

Study information

• Verified date: October 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it by comparing the results of healthy elderly participants to those of healthy young participants. The tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected.

This study will last up to approximately 19 days, not including screening. This study requires either one (Group 2) or two (Group 1) stays at the clinic each of at least four days/three nights. Participants will return for a follow-up seven days after last dose of study drug. Screening is required within 28 days prior to Day 1.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination.

• Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening.

Exclusion Criteria:

• Have known allergies to lasmiditan, related compounds or any components of the formulation.

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.

• Show evidence of active renal disease or estimated glomerular filtration rate (eGFR) less than 60 milliliter per minute (mL/min) per 1.73 m².

• Show evidence of or positive serology for human immunodeficiency virus (HIV) infection, hepatitis B or C.

• Are women with a positive pregnancy test or women who are lactating.

• Have a clinically significant abnormality in the neurological examination.

• Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.

• Have orthostatic hypotension with or without dizziness and/or syncope at screening or Day -1 upon repeat testing, or a history of it.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lasmiditan
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
United States	Covance Daytona Beach	Daytona Beach	Florida
United States	Covance Evansville	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan	Maximum Observed Drug Concentration (Cmax) of Lasmiditan.	Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Lasmiditan	Area under the concentration versus time curve from zero to infinity	Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours