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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01487239
First received: December 5, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Healthy Volunteer
Drug: [14C]-GDC-0980
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax) [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax) [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve extrapolated to infinity [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2) [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the urine radioactivity concentrations: renal clearance [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels. [ Time Frame: up to approximately 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: December 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
[14C]-GDC-0980 administered as a 10-mg oral dose
Drug: [14C]-GDC-0980
100 uCi of [14C]-GDC-0980 in total dose of 10 mg GDC-0980

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487239

Locations
United States, Wisconsin
Madison, Wisconsin, United States, 53704-2523
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01487239     History of Changes
Other Study ID Numbers: GP27915
Study First Received: December 5, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 22, 2014