A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects

This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GDC-0973

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
• No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations
• Negative test for selected drugs of abuse
• No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
• Sterile or agree to use an adequate contraception method
• Historically able to produce a minimum of 1 bowel movement per day

Exclusion Criteria:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance unless approved by the Investigator
• History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or hernia repair will be allowed
• History of Gilbert's Syndrome
• History of diabetes mellitus and/or elevated fasting glucose at baseline
• History or presence of an abnormal ECG
• History of alcoholism or drug addiction within 1 year prior Check-in
• Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in
• Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
• Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in
• Participation in any other investigational study drug or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
• Use of any prescription medications/products within 14 days prior to Check-in

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDC-0973 Single Arm	Drug: GDC-0973; Single oral dose of [14C]-GDC-0973

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Route of elimination of [14C]-GDC-0973	approximately 8 weeks
Pharmacokinetics: maximum observed concentration (Cmax)	approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)	approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve	approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant	approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life	approximately 8 weeks
Pharmacokinetics: apparent total clearance	approximately 8 weeks
Pharmacokinetics: apparent volume of distribution	approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces	approximately 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates	approximately 8 weeks
Pharmacokinetics: plasma concentration of GDC-0973	approximately 8 weeks
Safety: incidence of adverse events	approximately 8 weeks

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GP28369