Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects

A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14c]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects

This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least a 10-hour fast from food (not including water).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GDC-0941

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2523

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Within BMI range 18.5 to 29.9 kg/m2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Clinical laboratory evaluations within the reference range for the test laboratory
• Negative test for selected drugs of abuse at Screening and at Check-in
• Negative hepatitis panel (including hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [anti-HCV]) and negative HIV antibody screens
• Subjects will either be sterile or agree to use an approved form of contraception from Check-in until 45 days following Study Completion/ET
• Agree not to donate sperm from Screening throughout the study period and for at least 3 months (90 days) after the last dose of study drug
• A minimum of 1 to 2 bowel movements 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
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy and 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 to Check-in
• Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe
• Exposure to significant radiation within 12 months prior to Check-in
• Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in or positive urine drug screen for cotinine
• Participation in any other investigational study drug 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, unless deemed acceptable by the Investigator
• Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days prior to Check-in
• Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in, unless deemed acceptable by the Investigator
• Poor peripheral venous access
• Donation of blood from 30 days prior to Screening or of plasma from 2 weeks prior to Screening
• Receipt of blood products within 2 months prior to Check-in
• Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Experimental	Drug: GDC-0941; Single oral dose\n \n\n\n\n

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal phase elimination rate constant	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent total clearance	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent volume of distribution	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve extrapolated to infinity	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve from Hour 0 to the last measurable concentration	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: maximum observed concentration	up to approximately 6 weeks or early study discontinuation
Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: time to maximum concentration	up to approximately 6 weeks or early study discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of drug excreted in the feces over the sampling interval	up to approximately 6 weeks or early study discontinuation
Percent excreted in feces	up to approximately 6 weeks or early study discontinuation

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 18, 2011

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: GP27917