A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
A Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute Migraine
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.
Inclusion Criteria:
Subject has a diagnosis of migraine headache, with or without aura
Subject and subject's parent or legal guardian are able to read and write English
Subject must have a negative drug screen.
Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of acceptable contraception
Subject has one acceptable patch application site (left or right upper arm or thigh) that is relatively hair free and has no scars, tattoos, or abrasions
Subject must have a body mass index of between the 5th and 84th percentile for age and sex
Subject must be nonsmokers
Subject must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or grapefruit juice within 72 hours prior to admission to the clinic
Exclusion Criteria:
Subject has suspected or confirmed cardiovascular disease
Subject has a history of epilepsy or conditions associated with a lowered seizure threshold
Subject with Raynaud's disease
Subject has a history of basilar or hemiplegic migraines
Subject has a current diagnosis of a major depressive disorder
Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitors(SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs, including Wellbutrin), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) or preparations containing St. John's Wort within 1 month prior to screening and/or is planning to start any of these medications during the study and through the End of Study visit
Subject with a history of a significant allergy or hypersensitivity to any component of the study patch used in this study
Subject who has any generalized skin irritation or disease including eczema, psoriasis, melanoma, acne or contact dermatitis
Subject is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
Female subjects who are pregnant, breast feeding, or if of childbearing potential, is not using or is unwilling to use an effective form of contraception
Subject has known history of tolerability issues with sumatriptan
Subject has a history (within 1 year) or current evidence of drug or alcohol abuse or dependence
Subject has participated in a clinical study within 30 days of screening or is planning to participate in another clinical study within 30 days of last study visit
Subject is electrically sensitive (e.g., prior iontophoresis with adverse outcome related to the current delivered by the device).