NCT02684409

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: NuPathe Inc. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DRUG	PROT-CL-NP101-015.01

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2016-02-18
• Last updated: 2016-02-18