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CompletedNCT01711762Updated Nov 2, 2016

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

A Phase 1 interventional study of GDC-0973 in Healthy Volunteer, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Genentech, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    GDC-0973 Single Arm

    Drug: GDC-0973

Interventions

  • DrugGDC-0973

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

06

What researchers measure

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

07

Study locations

1 site
  • Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01711762
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Oct 22, 2012
Start date
Sep 2012
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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