Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase I, 2-Part, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Risdiplam and the Effect of Risdiplam on the Pharmacokinetics of Midazolam Following Oral Administration in Healthy Participants

Next Previous
Trial Profile

A Phase I, 2-Part, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Risdiplam and the Effect of Risdiplam on the Pharmacokinetics of Midazolam Following Oral Administration in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 May 2023

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Risdiplam (Primary) ; Midazolam
  • Indications Spinal muscular atrophy
  • Focus Pharmacokinetics
  • 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.
  • 04 Aug 2021 Results assessing the physiologically-based pharmacokinetic model-based extrapolate drug-drug interaction in pediatric patients with spinal muscular atrophy published in the Clinical Pharmacology and Therapeutics.
  • 01 Oct 2019 Status changed from recruiting to completed.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top