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

NCT01711762 | Completed Phase 1

• 1 other identifier: GP28369
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (9)

• Route of elimination of [14C]-GDC-0973

  approximately 8 weeks

• Pharmacokinetics: maximum observed concentration (Cmax)

  approximately 8 weeks

• Pharmacokinetics: time to maximum concentration (tmax)

  approximately 8 weeks

• Pharmacokinetics: area under the concentration-time curve

  approximately 8 weeks

• Pharmacokinetics: apparent terminal elimination phase rate constant

  approximately 8 weeks

• Pharmacokinetics: apparent terminal elimination phase half-life

  approximately 8 weeks

• Pharmacokinetics: apparent total clearance

  approximately 8 weeks

• Pharmacokinetics: apparent volume of distribution

  approximately 8 weeks

• Pharmacokinetics: amount total radioactivity in whole blood/urine/feces

  approximately 8 weeks

Secondary Outcomes (3)

• Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates

  approximately 8 weeks

• Pharmacokinetics: plasma concentration of GDC-0973

  approximately 8 weeks

• Safety: incidence of adverse events

  approximately 8 weeks

Study Arms (1)

GDC-0973 Single Arm

EXPERIMENTAL

Drug: GDC-0973

Interventions

GDC-0973 DRUG

Single oral dose of \[14C\]-GDC-0973

GDC-0973 Single Arm

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

cobimetinib

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)