Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects

NCT01474668 | Completed Phase 1

• 1 other identifier: GP27917
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of \[14C\]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least a 10-hour fast from food (not including water).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal phase elimination rate constant

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent total clearance

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent volume of distribution

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve extrapolated to infinity

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve from Hour 0 to the last measurable concentration

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: maximum observed concentration

  up to approximately 6 weeks or early study discontinuation

• Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: time to maximum concentration

  up to approximately 6 weeks or early study discontinuation

Secondary Outcomes (2)

• Amount of drug excreted in the feces over the sampling interval

  up to approximately 6 weeks or early study discontinuation

• Percent excreted in feces

  up to approximately 6 weeks or early study discontinuation

Study Arms (1)

A

EXPERIMENTAL

Experimental

Drug: GDC-0941

Interventions

GDC-0941 DRUG

Single oral dose\\n \\n\\n\\n\\n

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Within BMI range 18.5 to 29.9 kg/m2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Clinical laboratory evaluations within the reference range for the test laboratory
• 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
• Subjects will either be sterile or agree to use an approved form of contraception from Check-in until 45 days following Study Completion/ET
• Agree not to donate sperm from Screening throughout the study period and for at least 3 months (90 days) after the last dose of study drug
• A 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 (except that appendectomy and hernia repair will be allowed)
• 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 within 12 months prior to Check-in
• Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in or positive urine drug screen 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 (including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days prior to Check-in
• Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in, unless deemed acceptable by the Investigator
• Poor peripheral venous access

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704-2523, United States

Location

MeSH Terms

Interventions

2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine

Study Officials

• Scott Holden, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 18, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)