Status:
COMPLETED
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of \[14C\]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or surgically steril...
Eligibility Criteria
Inclusion
- Medically healthy as determined by the absence of clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
- Female subjects of non-childbearing potential, as defined as either: postmenopausal and without recent history of menorrhea as documented either by physician note or confirmed by serum follicle-stimulating hormone level consistent with postmenopausal status, or surgically sterile
- BMI range within 18.5 to 29.9 kg/m2, inclusive
- 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
- 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
- History or presence of inflammatory diseases, including those with small or large intestine inflammation such as Crohn's disease or ulcerative colitis, which required immunosuppressants
- Use of potent proton-pump inhibitors such as omeprazole, lansoprazole, dexlansoprazole, esomeprazole, pantoprazole, and rabeprazole
- 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 12 months prior to Check-in
- Use of any tobacco-containing or nicotine-containing products within 3 months/approximately 90 days prior to Check-in or positive urine screening 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 within 7 days prior to Check-in
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours
- 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 :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01487239
Start Date
December 1 2011
End Date
January 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Madison, Wisconsin, United States, 53704-2523