Healthy VolunteersPhase 1NCT00999128
A Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
A Phase 1 study testing GDC-0941 and rabeprazole in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United States.
Trial summary
This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GDC-0941 and rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2009to 26 Feb 2010
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, between 18 and 65 years of age, inclusive (Part 1 only)
- Male or female, between 18 and 45 years of age, inclusive (Part 2 only)
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs assessment
- Body Mass Index (BMI) between 18-30 kg/m^2 inclusive, with a body weight >50 kg
- Clinical laboratory evaluations within the reference range for the test laboratory
- Negative test for selected drugs of abuse at screening (does not include alcohol) and at check-in (does include alcohol)
- Negative HIV, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody screens
- Agreement to use an effective form of contraception for the duration of the study
Who cannot join
- History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, psychiatric disorders, or cancer
- History of inflammatory arthritis
- History of symptomatic hypotension
- History of severe physical injury, direct impact trauma, or neurological trauma within a specified timeframe prior to Day 1
- History of seizure disorders
- History of bipolar or major depressive disorder
Show all 23Show fewer
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (exceptions: appendectomy, hernia repair, and/or cholecystectomy)
- History or presence of an abnormal ECG
- Subjects with a history of ventricular dysrhythmias or with risk factors for ventricular dysrhythmias
- History of alcoholism, drug abuse, or drug addiction
- Use of any nicotine-containing or nicotine-replacement products within a specified timeframe prior to Day 1
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within a specified timeframe prior to Day 1
- Use of any prescription medications/products within a specified timeframe prior to Day 1 (exceptions: hormone replacement therapy [HRT], oral, implantable, or transdermal contraception)
- Receipt of any vaccination or immunization within a specified timeframe prior to Day 1
- Use of proton pump inhibitors or H2-receptor antagonists within a specified timeframe prior to Day 1
- Known hypersensitivity to rabeprazole or any of its components, or to derived products of benzimidazoles
- Use of any over-the-counter (OTC), non-prescription preparations within a specified timeframe prior to Day 1
- Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within a specified timeframe prior to Day 1
- Poor peripheral venous access
- Donation of blood or plasma within a specified timeframe prior to Day 1
- Receipt of blood products within a specified timeframe prior to Day 1
- Vegetarians who are unable to consume a high-fat meal
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Genentech Trial Information Support
South San Francisco, California, 94080
About this study
Official title: An Open-Label, Two-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
This is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1 are not eligible to participate in Part 2.
- Conditions
- Healthy Volunteers
- Being tested
- GDC-0941, rabeprazole
- Keywords
- PI3K inhibitor, PI3 kinase, PI3 kinase inhibitor
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0941Drug
Oral repeating dose
rabeprazoleDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: GDC-0941 |
| Part 2 | Experimental | Not described Receives: Drug: GDC-0941; Drug: rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)
Measured: Following administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study start26 Oct 2009
- Primary completion26 Feb 2010
- Study completion26 Feb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00999128
- Sponsor's protocol ID
- GDC4740g
- Status last verified
- Feb 2010
- First submitted
- 19 Oct 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0941 and the Effect of Food and Proton Pump Inhibition on GDC-0941 Tablet Pharmacokinetics in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00999128
- Acronym / sponsor ID
- GDC4740g
- Conditions
- Healthy Volunteers
- Keywords
- PI3K inhibitor, PI3 kinase, PI3 kinase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2009 (actual)
- Primary completion
- 26 Feb 2010 (actual)
- Study completion
- 26 Feb 2010 (actual)
- First posted
- 21 Oct 2009 (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 is a Phase I, randomized, two-part, single-center pharmacokinetics (PK) study to assess the relative bioavailability of capsule and tablet formulations of GDC-0941 in the fasted state (Part 1) and to determine the effect of food and proton pump inhibition on the PK of the tablet formulation of GDC-0941 (Part 2). Approximately 18 subjects will be enrolled in Part 1 and up to 32 subjects will be enrolled in Part 2. Subjects who participate in Part 1 are not eligible to participate in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: GDC-0941 |
| Part 2 | Experimental | Drug: GDC-0941, Drug: rabeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, between 18 and 65 years of age, inclusive (Part 1 only)
- Male or female, between 18 and 45 years of age, inclusive (Part 2 only)
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs assessment
- Body Mass Index (BMI) between 18-30 kg/m^2 inclusive, with a body weight >50 kg
- Clinical laboratory evaluations within the reference range for the test laboratory
Key exclusion criteria (23 listed)
- History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, psychiatric disorders, or cancer
- History of inflammatory arthritis
- History of symptomatic hypotension
- History of severe physical injury, direct impact trauma, or neurological trauma within a specified timeframe prior to Day 1
- 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-0941Oral repeating dose | Drug | Part 1, Part 2 |
| rabeprazoleOral repeating dose | Drug | Part 2 |
Primary outcome
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
PK parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration)
Time frame: Following administration of study drug
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 9 Feb 2017.
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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-0941 and rabeprazole in people with Healthy Volunteers, 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 8 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 9 Feb 2017. 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?
Incidence, nature, and severity of adverse events (time frame: Through study completion or early study discontinuation). The study lists 2 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 9 Feb 2017.