Migraine Headache Clinical Trial
Official title:
A Phase I, Three-Period, Three-Way, Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Bioavailability Study of Dihydroergotamine Mesylate (DHE) Administered by I123 Precision Olfactory Delivery (POD) Device Nasal Spray, DHE for Injection (Intravenous), and Migranal® Nasal Spray in Healthy Adult Subjects
A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE)
following a single dose administration of INP104 (DHE administered by I123 Precision
Olfactory Delivery (POD) Device Nasal Spray) to that of D.H.E. 45 for Injection (Intravenous)
and Migranal Nasal Spray in healthy adult subjects.
It is hypothesized that INP104 will address the current variability in nasal administration
and give more reproducible dose delivery compared to Migranal nasal spray.
Blood concentrations of all three investigational products will be compared for 48 hours
following dosing. The safety and tolerability of INP104 will be monitored throughout the
study.
INP104 has been developed for the treatment of acute migraine headache. The device in which
the drug will be delivered has been designed to deliver the medication to the upper nasal
cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the
dose being swallowed.
Approximately 36 participants in general good health (equal ratio of males and females
desired) will be enrolled and will be allocated to receive 3 treatments in a randomized
sequence. They will receive a single dose of INP104, a single dose of DHE via intravenous
injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where
no treatment will be administered for 7 days in between each treatment. Participants are
required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be
in the study for up to 43 days.
n/a
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