Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
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.