Healthy VolunteerPhase 1NCT01711762
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
A Phase 1 study testing GDC-0973 in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-0973
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- GDC-0973
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0973Drug
Single oral dose of [14C]-GDC-0973
| Study group | Role | What they receive |
|---|---|---|
| GDC-0973 Single Arm | Experimental | Not described Receives: Drug: GDC-0973 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Route of elimination of [14C]-GDC-0973
Measured: approximately 8 weeks
Pharmacokinetics: maximum observed concentration (Cmax)
Measured: approximately 8 weeks
Pharmacokinetics: time to maximum concentration (tmax)
Measured: approximately 8 weeks
Pharmacokinetics: area under the concentration-time curve
Measured: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase rate constant
Measured: approximately 8 weeks
Pharmacokinetics: apparent terminal elimination phase half-life
Measured: approximately 8 weeks
Pharmacokinetics: apparent total clearance
Measured: approximately 8 weeks
Pharmacokinetics: apparent volume of distribution
Measured: approximately 8 weeks
Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
Measured: approximately 8 weeks
Secondary outcomes (3)
Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
Measured: approximately 8 weeks
Pharmacokinetics: plasma concentration of GDC-0973
Measured: approximately 8 weeks
Safety: incidence of adverse events
Measured: approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711762
- Sponsor's protocol ID
- GP28369
- Status last verified
- Nov 2016
- First submitted
- 18 Oct 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01711762
- Acronym / sponsor ID
- GP28369
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDC-0973 Single Arm | Experimental | Drug: GDC-0973 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0973Single oral dose of [14C]-GDC-0973 | Drug | GDC-0973 Single Arm |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0973 in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Route of elimination of [14C]-GDC-0973 (time frame: approximately 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.