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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01474668
First received: November 16, 2011
Last updated: September 2, 2014
Last verified: September 2014

November 16, 2011
September 2, 2014
October 2011
October 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474668 on ClinicalTrials.gov Archive Site
  • Amount of drug excreted in the feces over the sampling interval [ Time Frame: up to approximately 6 weeks or early study discontinuation ] [ Designated as safety issue: No ]
  • Percent excreted in feces [ Time Frame: up to approximately 6 weeks or early study discontinuation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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 ex cretion study of [14C]-GDC 0941 administered as an oral dose to 6 healthy male s ubjects following at least a 10-hour fast from food (not including water).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
Drug: GDC-0941
Single oral dose\n \n\n\n\n
Experimental: A
Experimental
Intervention: Drug: GDC-0941
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474668
GP27917
Not Provided
Genentech
Genentech
Not Provided
Study Director: Scott Holden, M.D. Genentech
Genentech
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP