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

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: GDC-0941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01474668

GP27917

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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 (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
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