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

Healthy Volunteer Clinical Trial

Official title:

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711762
• Other study ID #: GP28369
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2012
• Last updated: November 1, 2016
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0973
Single oral dose of [14C]-GDC-0973

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Route of elimination of [14C]-GDC-0973		approximately 8 weeks	No
Primary	Pharmacokinetics: maximum observed concentration (Cmax)		approximately 8 weeks	No
Primary	Pharmacokinetics: time to maximum concentration (tmax)		approximately 8 weeks	No
Primary	Pharmacokinetics: area under the concentration-time curve		approximately 8 weeks	No
Primary	Pharmacokinetics: apparent terminal elimination phase rate constant		approximately 8 weeks	No
Primary	Pharmacokinetics: apparent terminal elimination phase half-life		approximately 8 weeks	No
Primary	Pharmacokinetics: apparent total clearance		approximately 8 weeks	No
Primary	Pharmacokinetics: apparent volume of distribution		approximately 8 weeks	No
Primary	Pharmacokinetics: amount total radioactivity in whole blood/urine/feces		approximately 8 weeks	No
Secondary	Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates		approximately 8 weeks	No
Secondary	Pharmacokinetics: plasma concentration of GDC-0973		approximately 8 weeks	No
Secondary	Safety: incidence of adverse events		approximately 8 weeks	No