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A Phase 1 Open-Label Study to Evaluate the Drug-Drug Interaction of Rifampin as a Strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participants

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Trial Profile

A Phase 1 Open-Label Study to Evaluate the Drug-Drug Interaction of Rifampin as a Strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Nov 2023

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At a glance

  • Drugs Soticlestat (Primary) ; Rifampicin
  • Indications Complex regional pain syndromes; Dravet syndrome; Epilepsy; Lennox-Gastaut syndrome; Liver failure; Myoclonic epilepsies; Tuberous sclerosis
  • Focus Pharmacokinetics
  • Sponsors Takeda
  • Most Recent Events

    • 06 Dec 2022 Results assessing the effects of itraconazole (strong CYP3A inhibitor), mefenamic acid (MA; strong UGT1A9 inhibitor) and rifampicin (strong CYP3A inducer) on the pharmacokinetics (PK) of soticlestat, presented at the 76th Annual Meeting of the American Epilepsy Society.
    • 04 Mar 2022 Status changed from recruiting to completed.
    • 26 Jan 2022 Planned End Date changed from 31 Dec 2021 to 27 Feb 2022.
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