A Study of Lasmiditan in Healthy Participants

NCT03182920 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16852H8H-MC-LAHA
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) 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

Study Arms (3)

200 mg Lasmiditan (Group 1 Elderly)

EXPERIMENTAL

200 milligrams (mg) lasmiditan on Day 1 of 1 of 2 dosing periods.

Drug: Lasmiditan

Placebo (Group 1 Elderly)

PLACEBO COMPARATOR

Placebo on Day 1 of 1 of 2 dosing periods.

Drug: Placebo

200 mg Lasmiditan (Group 2 Young)

EXPERIMENTAL

200 mg lasmiditan on Day 1.

Drug: Lasmiditan

Interventions

Lasmiditan DRUG

Oral administration

Also known as: LY573144

200 mg Lasmiditan (Group 1 Elderly); 200 mg Lasmiditan (Group 2 Young)

Placebo DRUG

Oral administration

Placebo (Group 1 Elderly)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Covance Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Covance Evansville

Evansville, Indiana, 47710, 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: GT60
• 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

Model Details: 2 Groups: Group 1 - Double-blind Randomized 2-Period Crossover, Group 2 - Open-label single dose

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: June 16, 2017
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: January 7, 2020
• Results First Posted: December 6, 2019

Record last verified: 2017-10

Locations

US (2)