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A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim

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Trial Profile

A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jan 2023

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At a glance

  • Drugs Olorofim (Primary) ; Olorofim (Primary) ; Olorofim (Primary)
  • Indications Coccidioidomycosis; Invasive bronchopulmonary aspergillosis; Mycoses
  • Focus Pharmacokinetics
  • Sponsors F2G

Most Recent Events

  • 07 Jan 2021 Status changed from recruiting to completed.
  • 23 Jul 2020 Number of arms changed from 3 to 5. Arm oral (intact tablet) and oral (NG tube) added to study protocol. Planned number of subjects also increased.
  • 23 Jul 2020 Planned number of patients changed from 12 to 24.

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