Clinical trial NCT01967966: A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
timeFrame: Days 1 to 11
measure: Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
timeFrame: Days 1 to 22
measure: Elimination & PK: Maximum concentration (Cmax) of GDC-0032
timeFrame: Days 1 to 22
measure: Elimination & PK: Area under the concentration-time curve (AUC)
timeFrame: Days 1 to 22
measure: Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
timeFrame: Days 1 to 22
Secondary outcomes:
measure: Elimination & PK: Metabolite identification in plasma, urine, & feces
timeFrame: Days 1 to 22
measure: Safety: Incidence of adverse events
timeFrame: 38 to 49 days
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: