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A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 May 2022

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At a glance

  • Drugs Baloxavir-marboxil (Primary) ; Oseltamivir
  • Indications Influenza virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CAPSTONE 1
  • Sponsors Shionogi

    • Most Recent Events

    • 18 May 2022 Results by deriving data from JapicCTI-153090, NCT02954354; NCT02949011, NCT03959332; KCT0003535, developing pharmacokinetics-time to alleviation of symptoms (PK-TTAS) model to study Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B.published in the Clinical Pharmacology and Therapeutics
    • 24 Jun 2021 Results of comparative analysis of baloxavir pharmacokinetics and simulated efficacy in chinese individuals and asian patients by using data of baloxavir clinical trials (a Phase I study (NCT03959332), a Phase II study (OwH; T0821), and Phase III studies in OwH (NCT02954354) and high risk (NCT02949011)), presented at the World Microbe Forum 2021.
    • 24 Jun 2021 Result (n=1781) of population pharmacokinetics model analysis from phase 2/3 data three studies (NCT02954354; NCT02949011 and NCT03959332) assessing the potential differences imposed by ethnicity on the PK-TTAS relationship that would justify a dose adaptation in Chinese patients, presented at the World Microbe Forum 2021.
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