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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01967966
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
30
Duration (Days)
15.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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 Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC]) [Days 1 to 11]

  2. Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval [Days 1 to 22]

  3. Elimination & PK: Maximum concentration (Cmax) of GDC-0032 [Days 1 to 22]

  4. Elimination & PK: Area under the concentration-time curve (AUC) [Days 1 to 22]

  5. Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces. [Days 1 to 22]

Secondary Outcome Measures

  1. Elimination & PK: Metabolite identification in plasma, urine, & feces [Days 1 to 22]

  2. Safety: Incidence of adverse events [38 to 49 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Madison Wisconsin United States 53704

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01967966
Other Study ID Numbers:
  • GP28755
First Posted:
Oct 23, 2013
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016

Study Results

No Results Posted as of Nov 2, 2016