A Study of Lasmiditan in Healthy Elderly Participants

NCT03406260 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17062H8H-MC-LAIG
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

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

Study Arms (3)

Lasmiditan 200 mg (milligrams)

EXPERIMENTAL

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

Lasmiditan 100 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lasmiditan DRUG

Administered orally.

Also known as: LY573144

Lasmiditan 100 mg; Lasmiditan 200 mg (milligrams)

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

lasmiditan

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: January 25, 2018
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)