Madison, Wisconsin, 53704, United States
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.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugSingle oral dose of [14C]-GDC-0973
Primary outcomes
-
Route of elimination of [14C]-GDC-0973
Time frame: approximately 8 weeks
-
Pharmacokinetics: maximum observed concentration (Cmax)
Time frame: approximately 8 weeks
-
Pharmacokinetics: time to maximum concentration (tmax)
Time frame: approximately 8 weeks
-
Pharmacokinetics: area under the concentration-time curve
Time frame: approximately 8 weeks
-
Pharmacokinetics: apparent terminal elimination phase rate constant
Time frame: approximately 8 weeks
-
Pharmacokinetics: apparent terminal elimination phase half-life
Time frame: approximately 8 weeks
-
Pharmacokinetics: apparent total clearance
Time frame: approximately 8 weeks
-
Pharmacokinetics: apparent volume of distribution
Time frame: approximately 8 weeks
-
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
Time frame: approximately 8 weeks
Secondary outcomes
-
Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
Time frame: approximately 8 weeks
-
Pharmacokinetics: plasma concentration of GDC-0973
Time frame: approximately 8 weeks
-
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.
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