A Phase 1 interventional study of RG1662 in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in Netherlands. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This is a single-center, open label, multiple dose study to investigate the pharmacokinetics of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male volunteers. The anticipated time of study treatment is 4 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RG1662
multiple doses of RG1662
Pharmacokinetics: Area under the concentration time curve (AUC)
Time frame: Selected Days between 1 and 28
Pharmacokinetics: maximum serum concentration
Time frame: Selected Days between 1 and 28
Pharmacokinetics: Clearance of 13C-RG1662
Time frame: Days 1 and 28
Pharmacokinetics: Bioavailability of 13C-RG1662
Time frame: Days 1 and 28
Amount of drug excreted in urine over the sampling interval
Time frame: Days 1 to 15
Amount of drug excreted in the feces over the sampling interval
Time frame: Pre-dose, days 1 to 15
Incidence of adverse events
Time frame: Up to approximately 10 weeks
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