Skip to main content
OpenTrials
Completed

NCT Number: NCT03406260

A Study of Lasmiditan in Healthy Elderly Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lasmiditan

Drug

Administered orally.

Other names: LY573144

Placebo

Drug

Administered orally.

Primary outcomes

  1. Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP)

    Time frame: Baseline through 24 hours after each administration of study drug

    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.

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan

    Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose

    Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.

  2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.