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An Open-Label, Pharmacokinetic Study to Evaluate the Pharmacokinetics and Relative Bioavailability of BIIB091 Formulations and to Assess the Impact of Food, a Proton Pump Inhibitor and CYP3A4 Inhibitor on BIIB091 Exposure Using the Selected Formulation in Healthy Subjects

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Trial Profile

An Open-Label, Pharmacokinetic Study to Evaluate the Pharmacokinetics and Relative Bioavailability of BIIB091 Formulations and to Assess the Impact of Food, a Proton Pump Inhibitor and CYP3A4 Inhibitor on BIIB091 Exposure Using the Selected Formulation in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs BIIB 091 (Primary) ; BIIB 091; Itraconazole; Rabeprazole
  • Indications Multiple sclerosis
  • Focus Pharmacokinetics
  • Sponsors Biogen
  • Most Recent Events

    • 13 Oct 2023 Results assessing several formulations and treatment regimens to reduce pharma- cokinetic (PK) variability and achieve steady state Ctrough > 221 ng/mL while limiting the drug exposure, presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis.
    • 18 Oct 2022 Status changed from recruiting to completed.
    • 03 Nov 2021 Planned number of patients changed from 44 to 52.
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