A Phase 1 interventional study of RO4917523 and RO4917523 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Drug: RO4917523
\[14C\]-labeled RO4917523, single oral dose
\[13C\]-labeled RO4917523, single intravenous tracer dose
Elimination: urinary and fecal recovery of total radioactivity
Time frame: Pre-dose and up to approximately Day 18 post-dose
Plasma concentrations of RO4917523
Time frame: Pre-dose and up to approximately Day 18 post-dose
Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling
Time frame: Pre-dose and up to approximately Day 18 post-dose
Absolute bioavailability: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to approximately Day 18 post-dose
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche