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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: GDC-0032

• Registration Number: NCT01967966
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Study Start: 2013-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elimination & PK	GDC-0032	-
Bioavailability	GDC-0032	-

Primary Outcome Measures

Name	Time	Method
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval	Days 1 to 22
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.	Days 1 to 22
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])	Days 1 to 11
Elimination & PK: Maximum concentration (Cmax) of GDC-0032	Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)	Days 1 to 22

Secondary Outcome Measures

Name	Time	Method
Elimination & PK: Metabolite identification in plasma, urine, & feces	Days 1 to 22
Safety: Incidence of adverse events	38 to 49 days