Healthy VolunteerPhase 1NCT01967966
A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers
A Phase 1 study testing GDC-0032 in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial summary
This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. 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-0032
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2013
- 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) 18 to 32 kg/m2, inclusive;
- Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
- Agree to use effective contraceptive methods as defined by protocol;
- Negative hepatitis panel and HIV screen;
- Sufficient bowel movements (minimum of 1 per day).
Who cannot join
- History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
- History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
- History of alcoholism or drug addiction within 1 year prior to drug administration;
- Tobacco or nicotine use within 6 months prior to study start;
- Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
- Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
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- Inability or unwillingness to swallow capsules;
- Participation in a drug study in which a drug was administered within 30 days prior to study start;
- Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
- Exposure to significant radiation within 12 months prior to study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1 STUDY TO INVESTIGATE THE ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS
This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0032
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0032Drug
Single oral dose
GDC-0032Drug
Single IV dose
| Study group | Role | What they receive |
|---|---|---|
| Bioavailability | Experimental | Not described Receives: Drug: GDC-0032 |
| Elimination & PK | Experimental | Not described Receives: Drug: GDC-0032 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
Measured: Days 1 to 11
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
Measured: Days 1 to 22
Elimination & PK: Maximum concentration (Cmax) of GDC-0032
Measured: Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)
Measured: Days 1 to 22
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
Measured: Days 1 to 22
Secondary outcomes (2)
Elimination & PK: Metabolite identification in plasma, urine, & feces
Measured: Days 1 to 22
Safety: Incidence of adverse events
Measured: 38 to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT01967966
- Sponsor's protocol ID
- GP28755
- Status last verified
- Nov 2016
- First submitted
- 18 Oct 2013
- 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 ABSOLUTE BIOAVAILABILITY OF GDC-0032 AND THE ABSORPTION, METABOLISM, AND EXCRETION OF [14C]-GDC-0032 IN HEALTHY MALE SUBJECTS
- ClinicalTrials.gov ID
- NCT01967966
- Acronym / sponsor ID
- GP28755
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Oct 2013 (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 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioavailability | Experimental | Drug: GDC-0032 |
| Elimination & PK | Experimental | Drug: GDC-0032 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
- Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
- Agree to use effective contraceptive methods as defined by protocol;
- Negative hepatitis panel and HIV screen;
- Sufficient bowel movements (minimum of 1 per day).
Key exclusion criteria (10 listed)
- History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
- History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
- History of alcoholism or drug addiction within 1 year prior to drug administration;
- Tobacco or nicotine use within 6 months prior to study start;
- Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
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-0032Single oral dose | Drug | Bioavailability, Elimination & PK |
| GDC-0032Single IV dose | Drug | Bioavailability |
Primary outcome
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC])
Time frame: Days 1 to 11
Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval
Time frame: Days 1 to 22
Elimination & PK: Maximum concentration (Cmax) of GDC-0032
Time frame: Days 1 to 22
Elimination & PK: Area under the concentration-time curve (AUC)
Time frame: Days 1 to 22
Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces.
Time frame: Days 1 to 22
2 secondary outcomes
Elimination & PK: Metabolite identification in plasma, urine, & feces
Time frame: Days 1 to 22
Safety: Incidence of adverse events
Time frame: 38 to 49 days
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.
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Screening Protocol
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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-0032 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 5 inclusion and 10 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?
Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC]) (time frame: Days 1 to 11). The study lists 5 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.