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An Open-Label, Single-Dose, Parallel-Group, Two-Part Study to Evaluate the Pharmacokinetics and Safety of Risdiplam in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

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Trial Profile

An Open-Label, Single-Dose, Parallel-Group, Two-Part Study to Evaluate the Pharmacokinetics and Safety of Risdiplam in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2022

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At a glance

  • Drugs Risdiplam (Primary)
  • Indications Spinal muscular atrophy
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 17 Mar 2022 Results assessing effect of mild or moderate hepatic impairment on the pharmacokinetics of risdiplam, published in the British Journal of Clinical Pharmacology
  • 08 Jan 2020 Status changed from recruiting to completed.
  • 25 Oct 2019 Planned End Date changed from 4 Oct 2019 to 3 Dec 2019.

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