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A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects

Trial Profile

A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Omaveloxolone (Primary) ; Digoxin; Gemfibrozil; Itraconazole; Metformin; Midazolam; Repaglinide; Rosuvastatin; Verapamil
  • Indications Brain disorders; Friedreich's ataxia; Malignant melanoma; Mitochondrial disorders; Ocular inflammation; Ocular pain
  • Focus Pharmacokinetics
  • Sponsors Biogen; Reata Pharmaceuticals

Most Recent Events

  • 12 Sep 2023 Results of drug-drug interaction (DDI) study determining the perpetrator and the victim DDI potential of omaveloxolone , presented at the 2023 American College of Clinical Pharmacology Annual Meeting
  • 14 Jan 2020 Status changed from recruiting to completed.
  • 08 Jul 2019 New trial record

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