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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474668
• Other study ID #: GP27917
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2011
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0941
Single oral dose\n \n\n\n\n

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Amount of drug excreted in the feces over the sampling interval		up to approximately 6 weeks or early study discontinuation	No
Secondary	Percent excreted in feces		up to approximately 6 weeks or early study discontinuation	No