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Clinical Trial Summary

The purpose of this single-center, open-label, non-randomized study is to assess the excretion balance, pharmacokinetics, metabolism and absolute oral bioavailability of [14C]-labeled idasanutlin administered orally and [13C]-labeled idasanutlin administered intravenously in a single cohort of eligible participants. Participants will be screened for participation in this study within 21 days of receiving the first dose of study drug on Day 1. Treatment period will continue up to Day 28 after which participants will enter 28 day follow-up or the optional treatment extension of idasanutlin, depending on safety parameters and as per opinion of the Investigator.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02828930
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 1
Start date September 8, 2016
Completion date June 19, 2017

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