A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

Healthy Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579940
• Other study ID #: 17010
• Secondary ID: H8H-JE-LAIE
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2018
• Est. completion date: August 9, 2018

Study information

• Verified date: August 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 9, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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• Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lasmiditan
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Lasmiditan in Each Period	PK: AUC(0-8) of Lasmiditan in Each Period was evaluated.	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
Secondary	PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period	PK: Cmax of Lasmiditan in Each Period was evaluated.	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