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

NCT ID: NCT01487239

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-01-31

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

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

\[14C\]-GDC-0980 administered as a 10-mg oral dose

Group Type: EXPERIMENTAL

[14C]-GDC-0980

Intervention Type: DRUG

100 uCi of \[14C\]-GDC-0980 in total dose of 10 mg GDC-0980

Interventions

[14C]-GDC-0980

100 uCi of \[14C\]-GDC-0980 in total dose of 10 mg GDC-0980

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

GP27915

Identifier Type: -

Identifier Source: org_study_id