Phase 1 Completed N=16 Basic Science

A Study of Lasmiditan in Participants With Migraine

Migraine Disorders

Source: ClinicalTrials.gov NCT03247790 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period — 233; 227 nanogram per milliliter (ng/mL)

Summary

The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it during an acute migraine attack and also during the time between acute migraine attacks. Information about any side effects that may occur will also be collected. This study includes two study periods. Each study period requires an overnight stay in the Clinical Research Unit (CRU) for at least one night (and up to three nights), followed by up to two outpatient appointments. This study will last approximately 5-6 weeks (not including screening). Follow-up is required four to seven days after last dose of investigational drug. Screening is required within 28 days prior to the start of the study. This study is for research purposes only and is not intended to treat any medical condition.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period	233; 227	—
PRIMARY PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period	1570; 1640	—
SECONDARY PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	14.5; 14.8; 319; 326; 77.2; 85.9	—
SECONDARY PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period	68.0; 77.8; 6180; 6380; 820; 949	—

Eligibility Criteria

Inclusion Criteria

Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or >95 mmHg
Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03247790). 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.