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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Administered orally
eStudySite
San Diego, California, United States
AGA Clinical Trials
Hialeah, Florida, United States
Meridien Research Inc.
Tampa, Florida, United States
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period
PK: Cmax of Lasmiditan in Each Period.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period
PK: AUC(0-∞) of Lasmiditan in Each Period.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose
PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period
PK: Cmax of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose
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
PK: AUC(0-∞) of Major Lasmiditan Metabolites \[M3, M8, M7, (S,R)-M18and (S,S)-M18\] in Each Period.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose
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