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A Phase 1, Single And Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study With Itraconazole, Midazolam and Fexofenadine Of Orally Administered AV078 In Healthy Adults

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Trial Profile

A Phase 1, Single And Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study With Itraconazole, Midazolam and Fexofenadine Of Orally Administered AV078 In Healthy Adults

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Feb 2025

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At a glance

  • Drugs AV 078 (Primary) ; Fexofenadine; Itraconazole; Midazolam
  • Indications Seizures
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Aeovian Pharmaceuticals

    • Most Recent Events

    • 30 Jan 2025 Planned End Date changed from 1 Dec 2024 to 15 May 2025.
    • 30 Jan 2025 Planned primary completion date changed from 1 Dec 2024 to 15 Apr 2025.
    • 28 Mar 2024 According to Aeovian Pharmaceuticals media release, the first cohort of participants dosed in this trial; The company also recently completed a $50 million financing, led by Hevolution. This financing will support the completion of the Phase 1 clinical trial in healthy volunteers and prepare for the start of a subsequent Phase 2 clinical trial in adult and pediatric patients with TSC refractory epilepsy.

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