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Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects Addendum: Phase 1, Randomised, Multi Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Relative Bioavailability and Food Effect of Single and Multiple Ascending Doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment With Itraconazole

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Trial Profile

Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects Addendum: Phase 1, Randomised, Multi Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Relative Bioavailability and Food Effect of Single and Multiple Ascending Doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment With Itraconazole

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 May 2023

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At a glance

  • Drugs Azetukalner (Primary) ; Itraconazole
  • Indications Major depressive disorder; Partial epilepsies; Tonic-clonic epilepsy
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Xenon Pharmaceuticals

Most Recent Events

  • 15 May 2023 Protocol of study has been amended to increase treatment arms to 5, change trial design to non randomized, to add study parts for PK study
  • 05 Jul 2021 According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified June 2018).
  • 22 Feb 2021 According to a Xenon Pharmaceuticals media release, data from this trial will be presented at ASENT 2021 virtual annual meeting of the American Society for Experimental Neurotherapeutics.

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