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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Safety- Percentage of Participants with Adverse Events
Time frame: 30 days
Patch Adherence Evaluation
Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))
Time frame: 4 hours
Skin Irritation Examination
Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)
Time frame: 10 days
Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last)
Time frame: 1 day
Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.
Time frame: 1 day
Maximum observed drug concentration (Cmax)
Time frame: 1 day
Time of maximum drug concentration (Tmax)
Time frame: 1 day
The terminal elimination rate constant (λz); calculated using non-linear regression Analysis
Time frame: 1 day
Terminal elimination half-life (t1/2); calculated as 0.693/λz2
Time frame: 1 day
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