Healthy VolunteerPhase 1NCT01473316
Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
A Phase 1 study testing GDC-0980 and Ketoconazole in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United States.
Trial summary
This will be an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980. 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 Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 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
- Healthy postmenopausal and/or surgically sterile adult nonsmoking female subject between 18 and 65 years of age, inclusive, with a body mass index of 18 to 32 kg/m2, inclusive
- 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) as determined by the investigator
- Female subject of nonchildbearing potential
Who cannot join
- History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological (including hypercholesterolemia and triglyceridemia), pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), 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 before Day 1 of Period 1
- History of seizure disorders
- History of bipolar or major depressive disorder
Show all 28Show 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 of active liver disease, including hepatitis or cirrhosis
- 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 determined to be clinically significant by the investigator and medical monitor
- History of alcoholism, drug abuse, or drug addiction
- Used any nicotine-containing or nicotine-replacement products within 6 months before Day 1 of Period 1
- Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives before Day 1 of Period 1
- Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) before Day 1 of Period 1, with the exception of hormone replacement therapy or 2 weeks' use of narcotics for pain, unless deemed acceptable by the investigator
- Used medications capable of inhibiting hepatic enzymes within 1 month or 5 half-lives before Day 1 of Period 1
- Received any vaccination or immunization within 1 month before Day 1 of Period 1
- Used proton pump inhibitors or histamine H2 receptor antagonists within 1 month before Day 1 of Period 1
- Known hypersensitivity to ketoconazole, or other azole antifungals
- Used any over-the-counter, nonprescription preparations within 7 days before Day 1 of Period 1, unless deemed acceptable by the investigator
- Used alcohol-containing, grapefruit-containing, or caffeine containing foods or beverages within 72 hours before Day 1 of Period 1, unless deemed acceptable by the investigator
- Poor peripheral venous access
- Donated blood within 2 weeks or plasma within 1 week before Day 1 of Period 1
- Received blood products within 2 months before Day 1 of Period 1
- Positive urine drug or alcohol screen
- Positive screen for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus types 1 and 2
- Diagnosed with a vitamin B12 deficiency
- Any acute or chronic condition that, in the opinion of the investigator, 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, Fixed-Sequence, 2-Period Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
This will be an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0980, Ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0980Drug
Single oral dose
KetoconazoleDrug
Repeating Oral Dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0980; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: maximum observed plasma concentration
Measured: Up to approximately 10 days
Pharmacokinetics: time to reach maximum observed plasma concentration
Measured: Up to approximately 10 days
Secondary outcomes (3)
Adverse events
Measured: Up to approximately 40 days
Clinical laboratory test results (hematology and serum chemistry)
Measured: Up to approximately 10 days
Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature)
Measured: Up to approximately 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 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
- 22 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
- NCT01473316
- Sponsor's protocol ID
- GP27913
- Status last verified
- Nov 2016
- First submitted
- 10 Nov 2011
- 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
- An Open-Label, Fixed-Sequence, 2-Period Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of GDC-0980
- ClinicalTrials.gov ID
- NCT01473316
- Acronym / sponsor ID
- GP27913
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Nov 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 an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0980, Drug: Ketoconazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy postmenopausal and/or surgically sterile adult nonsmoking female subject between 18 and 65 years of age, inclusive, with a body mass index of 18 to 32 kg/m2, inclusive
- 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) as determined by the investigator
- Female subject of nonchildbearing potential
Key exclusion criteria (28 listed)
- History or clinical manifestations of significant metabolic (including type 1 and 2 diabetes), hepatic, renal, hematological (including hypercholesterolemia and triglyceridemia), pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), 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 before Day 1 of Period 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-0980Single oral dose | Drug | A |
| KetoconazoleRepeating Oral Dose | Drug | A |
Primary outcome
Pharmacokinetics: maximum observed plasma concentration
Time frame: Up to approximately 10 days
Pharmacokinetics: time to reach maximum observed plasma concentration
Time frame: Up to approximately 10 days
3 secondary outcomes
Adverse events
Time frame: Up to approximately 40 days
Clinical laboratory test results (hematology and serum chemistry)
Time frame: Up to approximately 10 days
Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature)
Time frame: Up to approximately 8 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
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-0980 and Ketoconazole 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 28 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?
Pharmacokinetics: maximum observed plasma concentration (time frame: Up to approximately 10 days). 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 2 Nov 2016.