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A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects

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Trial Profile

A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Ecopipam (Primary) ; Atorvastatin; Bupropion; Caffeine; Dabigatran etexilate; Dextromethorphan; Midazolam; Midazolam; Omeprazole; Pitavastatin; Rosuvastatin
  • Indications Gilles de la Tourette's syndrome; Lesch-Nyhan syndrome; Restless legs syndrome; Speech disorders
  • Focus Pharmacokinetics
  • Sponsors Emalex Biosciences

    • Most Recent Events

    • 20 May 2021 Status changed from active, no longer recruiting to discontinued.(The study was stopped because A number of subjects withdrew consent leaving the study without adequate power to achieve itsprimary end points. )
    • 27 Apr 2021 Planned End Date changed from 1 Jul 2021 to 7 May 2021.
    • 27 Apr 2021 Status changed from recruiting to active, no longer recruiting.

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