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OpenTrials
Completed

NCT Number: NCT01967966

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GDC-0032

Drug

Single oral dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 23, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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