A Phase 1 interventional study of GDC-3280 and Placebo in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Basic science
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
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:
Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.
Drug: GDC-3280
Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
Drug: Placebo
Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\n
Drug: GDC-3280
Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\n
Drug: Placebo
GDC-3280 at various doses, depending on the cohort and treatment period
Placebo at various doses, depending on the cohort and treatment period
Number of participants experiencing an adverse event
Time frame: Up to approximately 6 months
Maximum concentration (Cmax) for GDC-3280
Time frame: Up to 4 days
Time to Cmax (Tmax) for GDC-3280
Time frame: Up to 4 days
Total serum clearance for GDC-3280
Time frame: Up to 4 days
Volume of distribution for GDC-3280
Time frame: Up to 4 days
Elimination half-life for GDC-3280
Time frame: Up to 4 days
Serum GDC-3280 concentration-time data by dosing group
Time frame: Up to 4 days
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.