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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01967966

Enrollment

Registered

2013-10-23

Start date

2013-11-30

Completion date

2013-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGGDC-0032

Single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval	Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)	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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026