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

Tracking Information
First Submitted Date ICMJE	November 16, 2011
First Posted Date ICMJE	November 18, 2011
Last Update Posted Date	November 2, 2016
Study Start Date ICMJE	October 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 16, 2011)	Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to approximately 6 weeks or early study discontinuation ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01474668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 16, 2011)	Amount of drug excreted in the feces over the sampling interval [ Time Frame: up to approximately 6 weeks or early study discontinuation ]; Percent excreted in feces [ Time Frame: up to approximately 6 weeks or early study discontinuation ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
Official Title ICMJE	A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14c]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
Brief 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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Healthy Volunteer
Intervention ICMJE	Drug: GDC-0941; Single oral dose\n \n\n\n\n
Study Arms	Experimental: A; Experimental; Intervention: Drug: GDC-0941
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 16, 2011)	5
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01474668
Other Study ID Numbers ICMJE	GP27917
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Genentech, Inc.
Study Sponsor ICMJE	Genentech, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Scott Holden, M.D. Genentech, Inc.
PRS Account	Genentech, Inc.
Verification Date	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP