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

NCT01487239 | Completed Phase 1

• 1 other identifier: GP27915
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax)

  up to approximately 5 weeks

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax)

  up to approximately 5 weeks

• 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

• 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

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2)

  up to approximately 5 weeks

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant

  up to approximately 5 weeks

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance

  up to approximately 5 weeks

• Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution

  up to approximately 5 weeks

Secondary Outcomes (4)

• Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval

  up to approximately 5 weeks

• Pharmacokinetic based on the urine radioactivity concentrations: renal clearance

  up to approximately 5 weeks

• Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine

  up to approximately 5 weeks

• Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels.

  up to approximately 5 weeks

Study Arms (1)

A

EXPERIMENTAL

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

Drug: [14C]-GDC-0980

Interventions

[14C]-GDC-0980 DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704-2523, United States

Location

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)