A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

NCT03579940 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17010H8H-JE-LAIE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.

  Baseline up to Day 20

Secondary Outcomes (2)

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

  Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose

• PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period

  Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose

Study Arms (4)

Lasmiditan - Japanese

EXPERIMENTAL

Single (50 milligram (mg), 100 mg, 200 mg, 400 mg) and repeated (2 × 200 mg) doses of Lasmiditan administered orally in up to three of three study periods.

Drug: Lasmiditan

Placebo - Japanese

PLACEBO COMPARATOR

Single and repeated (2 X placebo) doses of Placebo administered orally in up to one of three study periods.

Drug: Placebo

Lasmiditan - Caucasian

EXPERIMENTAL

Single (50 mg, 100 mg, 200 mg) dose of Lasmiditan administered orally in up to three of three study periods.

Drug: Lasmiditan

Placebo - Caucasian

PLACEBO COMPARATOR

Single dose of Placebo administered orally in up to one of three study periods.

Drug: Placebo

Interventions

Lasmiditan DRUG

Administered orally.

Also known as: LY573144

Lasmiditan - Caucasian; Lasmiditan - Japanese

Placebo DRUG

Administered orally.

Placebo - Caucasian; Placebo - Japanese

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
• Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

You may not qualify if:

• Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
• Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
• Have an abnormal supine blood pressure at screening.
• Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of \>20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of \>10 mmHg at screening.
• Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
• Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

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: 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: June 25, 2018
• First Posted: July 9, 2018
• Study Start: June 27, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)