A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
Abstract
This will be a Phase 1, multiple center, open label, single-dose study in otherwise healthy adolescent subjects with a history of acute migraine. Subjects will each receive one Zecuity patch application. Subjects will be admitted 2 hours prior to dosing on Day 1, and will remain in the clinical unit under supervision until the last pharmacokinetic (PK) sample is obtained. Blood will be obtained at prescribed times for PK analysis and safety assessments will be performed, including adverse event monitoring, 12-lead ECG test, patch adhesion evaluations, skin irritation evaluations, and vital signs.
Conditions: Acute Migraine.
Primary outcome: Safety- Percentage of Participants with Adverse Events; Patch Adherence Evaluation; Skin Irritation Examination; Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last); Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.; Maximum observed drug concentration (Cmax); Time of maximum drug concentration (Tmax); The terminal elimination rate constant (λz); calculated using non-linear regression Analysis; Terminal elimination half-life (t1/2); calculated as 0.693/λz2.
Enrollment: 37 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 37 participants or records.
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