Clinical trial NCT03579940: A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Official title: Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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* Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Day 20
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
timeFrame: 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
measure: PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
timeFrame: 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
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: