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A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants

Trial Profile

A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Oct 2023

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At a glance

  • Drugs Soticlestat (Primary) ; Itraconazole; Mefenamic acid
  • Indications Complex regional pain syndromes; Dravet syndrome; Epilepsy; Lennox-Gastaut syndrome; 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.
  • 01 Dec 2021 Status changed from active, no longer recruiting to completed.
  • 10 Nov 2021 Status changed from recruiting to active, no longer recruiting.

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