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

NCT01967966 | Completed Phase 1

• 1 other identifier: GP28755
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])

  Days 1 to 11

• Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval

  Days 1 to 22

• 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

• Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.

  Days 1 to 22

Secondary Outcomes (2)

• Elimination & PK: Metabolite identification in plasma, urine, & feces

  Days 1 to 22

• Safety: Incidence of adverse events

  38 to 49 days

Study Arms (2)

Bioavailability

EXPERIMENTAL

Drug: GDC-0032

Elimination & PK

EXPERIMENTAL

Drug: GDC-0032

Interventions

GDC-0032 DRUG

Single oral dose

Bioavailability; Elimination & PK

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)