A Phase 1 interventional study of GDC-0973 in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Genentech, Inc. · Phase 1 and Interventional
This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.
Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: GDC-0973
Single oral dose of \[14C\]-GDC-0973
Route of elimination of [14C]-GDC-0973
Time frame: approximately 8 weeks
Pharmacokinetics: maximum observed concentration (Cmax)
Time frame: approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)
Time frame: approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve
Time frame: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant
Time frame: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life
Time frame: approximately 8 weeks
Pharmacokinetics: apparent total clearance
Time frame: approximately 8 weeks
Pharmacokinetics: apparent volume of distribution
Time frame: approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
Time frame: approximately 8 weeks
Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
Time frame: approximately 8 weeks
Pharmacokinetics: plasma concentration of GDC-0973
Time frame: approximately 8 weeks
Safety: incidence of adverse events
Time frame: approximately 8 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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Genentech, Inc.