A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967966
• Other study ID #: GP28755
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2013
• Last updated: November 1, 2016
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0032
Single oral dose
• GDC-0032
Single IV dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])		Days 1 to 11	No
Primary	Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval		Days 1 to 22	No
Primary	Elimination & PK: Maximum concentration (Cmax) of GDC-0032		Days 1 to 22	No
Primary	Elimination & PK: Area under the concentration-time curve (AUC)		Days 1 to 22	No
Primary	Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.		Days 1 to 22	No
Secondary	Elimination & PK: Metabolite identification in plasma, urine, & feces		Days 1 to 22	No
Secondary	Safety: Incidence of adverse events		38 to 49 days	No