Clinical trial NCT01711762: A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Route of elimination of [14C]-GDC-0973
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: maximum observed concentration (Cmax)
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: time to maximum concentration (tmax)
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: area under the concentration-time curve
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: apparent terminal elimination phase rate constant
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: apparent terminal elimination phase half-life
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: apparent total clearance
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: apparent volume of distribution
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
timeFrame: approximately 8 weeks
Secondary outcomes:
measure: Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
timeFrame: approximately 8 weeks
measure: Pharmacokinetics: plasma concentration of GDC-0973
timeFrame: approximately 8 weeks
measure: Safety: incidence of adverse events
timeFrame: approximately 8 weeks
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: