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 (PODTM) Device Nasal Spray, DHE for Injection (Intravenous), and Migranal Nasal Spray in Healthy Adult Subjects

Trial Profile

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 (PODTM) Device Nasal Spray, DHE for Injection (Intravenous), and Migranal Nasal Spray in Healthy Adult Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Jul 2018

At a glance

  • Drugs Dihydroergotamine mesilate (Primary) ; Dihydroergotamine mesilate (Primary)
  • Indications Migraine
  • Focus Pharmacokinetics; Proof of concept
  • Sponsors Impel NeuroPharma
  • Most Recent Events

    • 01 Jul 2018 Results (n=28) presented at the 60th Annual Scientific Meeting of the American Headache Society.
    • 07 Feb 2018 According to an Impel NeuroPharma media release, the company is planning data readouts in 2018.
    • 07 Feb 2018 Primary endpoint has been met. (DHE pharmacokinetics), as reported in an Impel NeuroPharma media release.
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