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: July 7, 2014
Last verified: July 2014
  Purpose

This study will be an open-label, non-randomized, absorption, metabolism, and ex cretion study of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy p ostmenopausal 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 7, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 23, 2014