The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Administered orally.
Perserverance Research Center
Scottsdale, Arizona, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
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Meridien Research
Bradenton, Florida, United States
Meridien Research
Maitland, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, Japan
Clinical Research Hospital, Tokyo
Shinjuku-Ku, Tokyo, Japan
...and 1 more locations