Skip to main content
OpenTrials
Completed

NCT Number: NCT01711762

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0973

Drug

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

Primary outcomes

  1. Route of elimination of [14C]-GDC-0973

    Time frame: approximately 8 weeks

  2. Pharmacokinetics: maximum observed concentration (Cmax)

    Time frame: approximately 8 weeks

  3. Pharmacokinetics: time to maximum concentration (tmax)

    Time frame: approximately 8 weeks

  4. Pharmacokinetics: area under the concentration-time curve

    Time frame: approximately 8 weeks

  5. Pharmacokinetics: apparent terminal elimination phase rate constant

    Time frame: approximately 8 weeks

  6. Pharmacokinetics: apparent terminal elimination phase half-life

    Time frame: approximately 8 weeks

  7. Pharmacokinetics: apparent total clearance

    Time frame: approximately 8 weeks

  8. Pharmacokinetics: apparent volume of distribution

    Time frame: approximately 8 weeks

  9. Pharmacokinetics: amount total radioactivity in whole blood/urine/feces

    Time frame: approximately 8 weeks

Secondary outcomes

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

    Time frame: approximately 8 weeks

  2. Pharmacokinetics: plasma concentration of GDC-0973

    Time frame: approximately 8 weeks

  3. Safety: incidence of adverse events

    Time frame: approximately 8 weeks

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 22, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.