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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487239
• Other study ID #: GP27915
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: November 1, 2016
• Start date: December 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• [14C]-GDC-0980
100 uCi of [14C]-GDC-0980 in total dose of 10 mg GDC-0980

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax)		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax)		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t)		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve extrapolated to infinity		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2)		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance		up to approximately 5 weeks	No
Primary	Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution		up to approximately 5 weeks	No
Secondary	Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval		up to approximately 5 weeks	No
Secondary	Pharmacokinetic based on the urine radioactivity concentrations: renal clearance		up to approximately 5 weeks	No
Secondary	Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine		up to approximately 5 weeks	No
Secondary	Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels.		up to approximately 5 weeks	No