A Study of Lasmiditan in Healthy Elderly Participants

A Study to Investigate the Cardiovascular Effects of Lasmiditan in Healthy Elderly Subjects

The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as 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 in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are overtly healthy males or females, as determined through 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 known allergies to lasmiditan, related compounds, or any components of the formulation.
• Are persons who have previously received lasmiditan.
• Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.
• Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
• Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate <60 milliliters per minute per 1.73 meter squared (mL/min/m²).
• Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lasmiditan 200 mg (milligrams); Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliter) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: Lasmiditan 100 mg; Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Placebo Comparator: Placebo; Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.	Drug: Placebo; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP)	Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant.	Baseline through 24 hours after each administration of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan	PK: Area under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Lasmiditan.	Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 17062; H8H-MC-LAIG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No