A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants

NCT04881747 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17016H8H-MC-LAIA
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare the amount of lasmiditan that gets into the blood stream and how long it takes the body to get rid of it, when given as a oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The information about any adverse effects experienced will be collected and the tolerability of lasmiditan when administered as OD tablet will also be evaluated. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 5 weeks, including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  PK: Cmax of Lasmiditan.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

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

  PK: AUC\[0-inf\] of Lasmiditan.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

• PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Lasmiditan

  PK: AUC\[0-tlast\] of Lasmiditan.

  Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24, 48, 72, 96 and 120 hours post-dose

Study Arms (3)

100 milligram (mg) Lasmiditan immediate release (IR) (Reference)

ACTIVE COMPARATOR

Participants received 100 mg lasmiditan as IR tablet formulation administered orally.

Drug: Lasmiditan

100 mg Lasmiditan oral disintegrating (OD) Without Water (Test)

EXPERIMENTAL

Participants received 100 mg lasmiditan as OD tablet formulation administered orally without water.

Drug: Lasmiditan

100 mg Lasmiditan OD With Water (Test)

EXPERIMENTAL

Participants received 100 mg lasmiditan as OD tablet formulation administered orally with water.

Drug: Lasmiditan

Interventions

Lasmiditan DRUG

Administered orally.

Also known as: LY573144

100 mg Lasmiditan OD With Water (Test); 100 mg Lasmiditan oral disintegrating (OD) Without Water (Test); 100 milligram (mg) Lasmiditan immediate release (IR) (Reference)

Eligibility Criteria

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

You may qualify if:

• Are overtly healthy as determined by medical evaluation.
• Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

You may not qualify if:

• Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan, or a history of significant atopy.
• Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.
• Have clinically significant abnormalities on ECG, as determined by investigator.
• Have a history or presence of cardiovascular, respiratory, 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 interventions; or of interfering with the interpretation of data.
• Have used or are intending to use over-the-counter or prescription medication, including dietary supplements, within 14 days prior to dosing and until study discharge (apart from occasional acetaminophen, hormonal contraception, or hormone-replacement therapy).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, 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: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 11, 2021
• Study Start: May 14, 2021
• Primary Completion: July 24, 2021
• Study Completion: July 24, 2021
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)