A Study of Lasmiditan in Healthy Japanese and Caucasian Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 64
Updated:8/18/2018
Start Date:June 27, 2018
End Date:August 9, 2018

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

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.


Inclusion Criteria:

- Are overtly healthy Japanese (first generation) or Caucasian males or females, as
determined by medical history and physical examination to qualify as first generation
Japanese, the participant, the participant's biological parents, and all of the
participant's biological grandparents must be of exclusive Japanese descent and born
in Japan.

- 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- Have previously received the investigational product in this study, withdrawn from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
We found this trial at
1
site
Dallas, Texas 75247
Principal Investigator: C Cirstea
Phone: 469-513-6727
?
mi
from
Dallas, TX
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