ZEST

Zephyr Powder is being developed for the treatment of Migraines. Migraines are a nervous system disorder which are characterised by severe headaches that distinguish themselves from typical headaches. Alongside intense head pain, individuals experiencing migraines often encounter symptoms such as sensitivity to light and sound, nausea, and in some cases, visual disturbances like seeing flashing lights.
Dihydroergotamine mesylate (DHE) is a well-established active ingredient with over 50 years of use in the treatment of migraines through several different formulations and ways to administer it. DHE works by making the blood vessels in and around the brain narrower, therefore relieving symptoms of migraines. Vectura Inc. (the sponsor of this study) are developing a DHE inhalation powder using an investigational Open-Inhale-Close (OIC)-dry powder inhaler (DPI) which is hoped to improve how quickly DHE works, how much of it can be absorbed into the blood stream, and to reduce the likelihood of side effects.

The purpose of this study is to:
–  Measure the extent of a single dose of Zephyr powder and a single dose of DHE administered intravenously (IV) that reaches the blood circulation (Bioavailability), in healthy participants.
– Measure levels of Zephyr powder (and its byproducts) in the blood over time, following a single dose  (pharmacokinetics)
– Evaluate how safe and well tolerated Zephyr powder is, in healthy participants.

It is an investigational drug because it has not been approved by MedSafe or other drug regulatory authorities.

This study (2023 FULL 18562) is being funded by Vectura Fertin and has been approved by the Health and Disability Ethics Committee.

Study Visits: 3 night stay + 1 phone call

Reimbursement: $2,500 (less tax)