Phase 1
Completed N=27
A Study of Lasmiditan in Healthy Japanese and Caucasian Participants
Healthy
Source: ClinicalTrials.gov NCT03579940 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period |
362; 366; 791; 826; 1540; 2120 | — |
| SECONDARY PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period |
54.1; 52.4; 122; 101; 249; 309 | — |
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- Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan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
Data sourced from ClinicalTrials.gov (NCT03579940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.