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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01967966
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: GDC-0032 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Bioavailability Drug: GDC-0032
Single oral dose

Drug: GDC-0032
Single IV dose

Experimental: Elimination & PK Drug: GDC-0032
Single oral dose

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

Secondary Outcome Measures :
  1. Elimination & PK: Metabolite identification in plasma, urine, & feces [ Time Frame: Days 1 to 22 ]
  2. Safety: Incidence of adverse events [ Time Frame: 38 to 49 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01967966

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United States, Wisconsin
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc. Identifier: NCT01967966    
Other Study ID Numbers: GP28755
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016