Status:
COMPLETED
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01474668
Start Date
October 1 2011
End Date
October 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Madison, Wisconsin, United States, 53704-2523