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A two-part, phase 1, randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of fenebrutinib in healthy subjects (part A) and a randomized, single-dose, placebo- and positive-controlled, crossover phase 1 study to evaluate the effect of fenebrutinib on the QT/QTC interval in healthy subjects (part B)

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Trial Profile

A two-part, phase 1, randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of fenebrutinib in healthy subjects (part A) and a randomized, single-dose, placebo- and positive-controlled, crossover phase 1 study to evaluate the effect of fenebrutinib on the QT/QTC interval in healthy subjects (part B)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Jun 2024

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At a glance

  • Drugs Fenebrutinib (Primary) ; Moxifloxacin
  • Indications Chronic urticaria; Multiple sclerosis; Systemic lupus erythematosus
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Genentech; Roche
  • Most Recent Events

    • 18 Apr 2024 Results evaluating the safety, tolerability and pharmacokinetics of fenebrutinib and its effect on cardiac repolarization in healthy participants presented at the 76th Annual Meeting of the American Academy of Neurology 2024
    • 01 Aug 2022 Status changed from recruiting to completed.
    • 01 Aug 2022 Planned End Date changed from 20 Oct 2021 to 21 Aug 2022.
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