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A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending-Dose(SAD), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food and the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of RO7034067), and Pharmacodynamics of RO7034067 Following Oral Administration in Healthy Subjects

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Trial Profile

A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending-Dose(SAD), Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food and the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of RO7034067), and Pharmacodynamics of RO7034067 Following Oral Administration in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 May 2023

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At a glance

  • Drugs Risdiplam (Primary) ; Itraconazole
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions
  • Sponsors Roche

Most Recent Events

  • 06 May 2023 Results assessing the in vivo FMO3 ontogeny by mechanistic population pharmacokinetic (Mech-PPK) modelling of risdiplam using the data collected healthy individuals or SMA patients who participated in five clinical trials (NCT02633709, NCT03032172, NCT02908685, NCT02913482, NCT03988907, published in the Clinical Pharmacokinetics.
  • 10 Oct 2018 Results assessing the pharmacokinetics and pharmacodynamics of risdiplam in healthy male volunteers, published in the British Journal of Clinical Pharmacology.
  • 01 Sep 2016 Status changed from active, no longer recruiting to completed.

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