Madison, Wisconsin, 53704, United States
NCT Number: NCT01967966
A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers
This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
- Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
- Agree to use effective contraceptive methods as defined by protocol;
- Negative hepatitis panel and HIV screen;
- Sufficient bowel movements (minimum of 1 per day).
Exclusion criteria
- History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
- History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
- History of alcoholism or drug addiction within 1 year prior to drug administration;
- Tobacco or nicotine use within 6 months prior to study start;
- Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
- Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
- Inability or unwillingness to swallow capsules;
- Participation in a drug study in which a drug was administered within 30 days prior to study start;
- Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
- Exposure to significant radiation within 12 months prior to study start.
Treatment and study plan
GDC-0032
DrugSingle oral dose
Primary outcomes
-
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
Time frame: Days 1 to 11
-
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
Time frame: Days 1 to 22
-
Elimination & PK: Maximum concentration (Cmax) of GDC-0032
Time frame: Days 1 to 22
-
Elimination & PK: Area under the concentration-time curve (AUC)
Time frame: Days 1 to 22
-
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
Time frame: Days 1 to 22
Secondary outcomes
-
Elimination & PK: Metabolite identification in plasma, urine, & feces
Time frame: Days 1 to 22
-
Safety: Incidence of adverse events
Time frame: 38 to 49 days
Sponsors and collaborators
Lead sponsor
Genentech, Inc.
Industry
Registry information
Official study title
A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Oct 23, 2013
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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