Healthy VolunteerPhase 1NCT01287091
A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
A Phase 1 study testing GDC-0980 and rabeprazole in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial summary
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-0980 and rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2010to 3 Feb 2011
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoking with a body mass index of 18 to 32 kg/m2
- Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs)
- Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile
Who cannot join
- History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer
- History of inflammatory arthritis
- History of symptomatic hypotension
- History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start
- History of seizure disorders
- History of bipolar or major depressive disorder
Show all 23Show fewer
- History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed
- History or presence of an abnormal ECG
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- Abnormality on the chest x-ray at Screening
- History of alcoholism, drug abuse, or drug addiction
- Used any nicotine-containing or nicotine-replacement products within 6 months prior to study start
- Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives prior to study start
- Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) prior to study start, with the exception of hormone-replacement therapy or 2 weeks' use of narcotics for pain
- Received any vaccination or immunization within 1 month prior to study start
- Used PPIs or histamine H2-receptor antagonists within 1 month prior to study start
- Hypersensitivity to rabeprazole, or any of its components, or to derived products of benzimidazoles (for Part 3 only)
- Poor peripheral venous access
- Received blood products within 2 months prior to study start
- Positive urine drug or alcohol screen
- Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
- Unable to consume a high-fat meal (for Parts 2 and 3 only)
- Acute or chronic condition that would limit the subject's ability to complete or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0980, rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0980Drug
Oral tablet dose
GDC-0980Drug
Oral capsule dose
GDC-0980Drug
Oral tablet dose in fed state
GDC-0980Drug
Oral repeating dose in fasting state
GDC-0980Drug
Oral repeating dose in fed state
GDC-0980Drug
Oral tablet in a fasting state
rabeprazoleDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: GDC-0980 |
| Part 2 | Experimental | Not described Receives: Drug: GDC-0980 |
| Part 3: Group A | Experimental | Not described Receives: Drug: GDC-0980; Drug: rabeprazole |
| Part 3: Group B | Experimental | Not described Receives: Drug: GDC-0980; Drug: rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration
Measured: Up to day 10
Time to maximum observed plasma concentration
Measured: Up to day 10
Plasma half-life
Measured: Up to day 10
Oral clearance
Measured: Up to day 10
Volume of distribution
Measured: Up to day 10
Minimum plasma concentration
Measured: Up to day 10
Secondary outcomes (3)
Incidence of adverse events
Measured: Up to day 68
Nature of adverse events
Measured: Up to day 68
Severity of adverse events
Measured: Up to day 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study start14 Oct 2010
- Primary completion3 Feb 2011
- Study completion3 Feb 2011
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Holden, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287091
- Sponsor's protocol ID
- PIM4930g
- Status last verified
- Dec 2022
- First submitted
- 7 Jan 2011
- Last updated
- 13 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet
- ClinicalTrials.gov ID
- NCT01287091
- Acronym / sponsor ID
- PIM4930g
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2010 (actual)
- Primary completion
- 3 Feb 2011 (actual)
- Study completion
- 3 Feb 2011 (actual)
- First posted
- 1 Feb 2011 (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 will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: GDC-0980 |
| Part 2 | Experimental | Drug: GDC-0980 |
| Part 3: Group A | Experimental | Drug: GDC-0980, Drug: rabeprazole |
| Part 3: Group B | Experimental | Drug: GDC-0980, Drug: rabeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nonsmoking with a body mass index of 18 to 32 kg/m2
- Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs)
- Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile
Key exclusion criteria (23 listed)
- History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer
- History of inflammatory arthritis
- History of symptomatic hypotension
- History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start
- History of seizure disorders
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-0980Oral tablet dose | Drug | Part 1 |
| GDC-0980Oral capsule dose | Drug | Part 1 |
| GDC-0980Oral tablet dose in fed state | Drug | Part 2 |
| GDC-0980Oral repeating dose in fasting state | Drug | Part 3: Group A |
| GDC-0980Oral repeating dose in fed state | Drug | Part 3: Group B |
| GDC-0980Oral tablet in a fasting state | Drug | Part 2 |
| rabeprazoleOral repeating dose | Drug | Part 3: Group A, Part 3: Group B |
Primary outcome
Maximum plasma concentration
Time frame: Up to day 10
Time to maximum observed plasma concentration
Time frame: Up to day 10
Plasma half-life
Time frame: Up to day 10
Oral clearance
Time frame: Up to day 10
Volume of distribution
Time frame: Up to day 10
Minimum plasma concentration
Time frame: Up to day 10
3 secondary outcomes
Incidence of adverse events
Time frame: Up to day 68
Nature of adverse events
Time frame: Up to day 68
Severity of adverse events
Time frame: Up to day 68
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 13 Dec 2022.
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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.
Scott Holden, M.D. 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-0980 and rabeprazole 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 3 inclusion and 23 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 13 Dec 2022. 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?
Maximum plasma concentration (time frame: Up to day 10). The study lists 6 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 13 Dec 2022.