Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:8/3/2016
Start Date:December 2011
End Date:January 2012

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A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female Subjects

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 sterile female subjects following at least a 10-hour fast from food (not
including water).


Inclusion Criteria:

- 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 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

- 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
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