Clinical trial NCT03182920: A Study of Lasmiditan in Healthy Participants
Official title: Effect of Age on the Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
timeFrame: 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
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Daytona Beach
state: Florida
city: Evansville
country: United States
facility: Covance Evansville
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: