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: July 7, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Healthy Volunteer
Drug: GDC-0941
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5
Study Start Date: October 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Experimental
Drug: GDC-0941
Single oral dose\n \n\n\n\n

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01474668

Locations
United States, Wisconsin
Madison, Wisconsin, United States, 53704-2523
Sponsors and Collaborators
Genentech
Investigators
Study Director: Scott Holden, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01474668     History of Changes
Other Study ID Numbers: GP27917
Study First Received: November 16, 2011
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014