A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: GDC-0973

Study type: Interventional

Funder types: Industry

Identifiers

NCT01711762

GP28369

Details and patient eligibility

About

This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
• No clinically significant findings from medical history, 12-lead ECG, and vital signs and laboratory evaluations
• Negative test for selected drugs of abuse
• No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
• Sterile or agree to use an adequate contraception method
• Historically able to produce a minimum of 1 bowel movement 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 unless approved by the Investigator
• History of stomach or intestinal surgery or resection (including a cholecystectomy) that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and/or 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 Check-in
• Participation in more than one other radiolabeled investigational study drug trial within 12 months prior to Check-in
• Exposure to significant radiation within 12 months prior to Check-in study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
• Use of any tobacco-containing or nicotine-containing products within 6 months prior to Check-in
• Participation in any other investigational study drug or biologic agent 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

Trial design

6 participants in 1 patient group

GDC-0973 Single Arm

Experimental group

Treatment:

Drug: GDC-0973