HealthyPhase 1NCT00991718
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
A Phase 1 study testing GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled) and CDC-0449 oral suspension (labeled) in people with Healthy, run by Genentech, Inc..
Trial summary
This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). 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
- What is being tested?
- GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled) and CDC-0449 oral suspension (labeled)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Aug 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Non-childbearing potential
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
- In good health, determined by no clinically significant findings on physical examination, medical history, 12-lead ECG, and vital signs
- Negative test for drugs of abuse at screening (does not include alcohol) and at admission to the clinical research facility (does include alcohol)
Who cannot join
- History or clinical manifestations of clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urologic, neurologic, inflammatory, or psychiatric disorders, or cancer
- History of symptomatic hypotension, idiopathic orthostatic hypotension, or other autonomous-failure syndromes
- History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to Day -1
- History of stomach or intestinal surgery, stomach disease, or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy are allowed)
- History of alcoholism, drug abuse, or drug addiction (including soft drugs like cannabis products)
- Use of any prescription medications/products, including known enzyme-inducing/inhibiting agents, over-the-counter medication, or other non-prescription preparations (including supplements, vitamins, minerals, phytotherapeutic/herbal/ plant-derived preparations, the tryptophans, and St. John's wort or other hypericum perforatum-containing substance) within 2 weeks prior to Day -1, with the exception of hormone-replacement therapy
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- Participation in any other investigational drug study in which receipt of an investigational study drug occurred within 60 days prior to Day -1 or within 5 times the elimination half-life of the respective drug; participation in a trial involving administration of ^1^4C-radiolabeled compound(s) within 6 months prior to Day -1; participation in more than two other drug trials within 1 year prior to Day -1
- Receipt of any vaccination or immunization within 1 month prior to Day -1
- Use of any nicotine-containing or nicotine-replacement products within 6 months prior to Day -1
- Consumption of alcohol or methylxanthine-containing beverages or food
- Receipt of blood products within 2 months prior to Day -1
- Donation of > 100 mL of blood within 60 days prior to Day -1; donation of > 1.0 litres of blood within 10 months prior to Day -1
- Irregular defecation pattern, i.e., less than once per 2 days within 6 months prior to Day -1; acute constipation problems within 3 weeks prior to Day -1 (Part B subjects only)
- Poor peripheral venous access
About this study
Official title: A Phase I, Open-Label Absorption, Distribution, Metabolism, and Excretion (ADME) Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.
- Conditions
- Healthy
- Being tested
- GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled), CDC-0449 oral suspension (labeled)
- Keywords
- GDC0449
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0449 oral capsules (non-labeled)Drug
150 mg oral capsule
GDC-0449 IV injection (labeled)Drug
10 mcg (in 2 mL) IV dose of 14C-GDC-0449
CDC-0449 oral suspension (labeled)Drug
30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449. Receives: Drug: GDC-0449 oral capsules (non-labeled); Drug: GDC-0449 IV injection (labeled) |
| B | Experimental | On Day 1, subjects received a single oral dose of 14C-GDC-0449. Receives: Drug: CDC-0449 oral suspension (labeled) |
| C | Experimental | On Days 1-7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449. Receives: Drug: GDC-0449 oral capsules (non-labeled); Drug: GDC-0449 IV injection (labeled) |
| D | Experimental | On Days 1-6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449. Receives: Drug: GDC-0449 oral capsules (non-labeled); Drug: CDC-0449 oral suspension (labeled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B])
Measured: Until study discontinuation
Secondary outcomes (1)
Safety outcome measures (incidence, nature, and severity of adverse events; change in clinical laboratory results; change in vital signs; change in electrocardiogram [ECG]; and change in physical examination findings)
Measured: Until study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Low, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991718
- Sponsor's protocol ID
- SHH4683g
- Status last verified
- Jun 2017
- First submitted
- 6 Oct 2009
- Last updated
- 26 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Absorption, Distribution, Metabolism, and Excretion (ADME) Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
- ClinicalTrials.gov ID
- NCT00991718
- Acronym / sponsor ID
- SHH4683g
- Conditions
- Healthy
- Keywords
- GDC0449
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 8 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 an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and extent of metabolism of GDC-0449 (Part B). Parts A and B will be conducted sequentially, with ≥ 7 days between dosing the sixth subject in Part A and dosing the first subject in Part B. In each part, 6 healthy female subjects of non-childbearing potential, between 18 and 65 years of age (inclusive), will be dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0449 oral capsules (non-labeled), Drug: GDC-0449 IV injection (labeled)On Day 1, subjects received a single oral dose of non-labeled GDC-0449 and a single IV tracer dose of 14C-GDC-0449. |
| B | Experimental | Drug: CDC-0449 oral suspension (labeled)On Day 1, subjects received a single oral dose of 14C-GDC-0449. |
| C | Experimental | Drug: GDC-0449 oral capsules (non-labeled), Drug: GDC-0449 IV injection (labeled)On Days 1-7, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects also received a single IV tracer dose of 14C-GDC-0449. |
| D | Experimental | Drug: GDC-0449 oral capsules (non-labeled), Drug: CDC-0449 oral suspension (labeled)On Days 1-6, subjects received a single oral dose of non-labeled GDC-0449. On Day 7, subjects received a single oral dose of 14C-GDC-0449. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Non-childbearing potential
- Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
- In good health, determined by no clinically significant findings on physical examination, medical history, 12-lead ECG, and vital signs
- Negative test for drugs of abuse at screening (does not include alcohol) and at admission to the clinical research facility (does include alcohol)
Key exclusion criteria (14 listed)
- History or clinical manifestations of clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, endocrine, gastrointestinal (including gastric or duodenal ulcers), urologic, neurologic, inflammatory, or psychiatric disorders, or cancer
- History of symptomatic hypotension, idiopathic orthostatic hypotension, or other autonomous-failure syndromes
- History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to Day -1
- History of stomach or intestinal surgery, stomach disease, or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy are allowed)
- History of alcoholism, drug abuse, or drug addiction (including soft drugs like cannabis products)
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-0449 oral capsules (non-labeled)150 mg oral capsule | Drug | A, C, D |
| GDC-0449 IV injection (labeled)10 mcg (in 2 mL) IV dose of 14C-GDC-0449 | Drug | A, C |
| CDC-0449 oral suspension (labeled)30-mL oral suspension containing 6.5 mcg 14CGDC-0449 and 150 mg GDC-0449 | Drug | B, D |
Primary outcome
PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B])
Time frame: Until study discontinuation
1 secondary outcome
Safety outcome measures (incidence, nature, and severity of adverse events; change in clinical laboratory results; change in vital signs; change in electrocardiogram [ECG]; and change in physical examination findings)
Time frame: Until study discontinuation
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 26 Jun 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.
Jennifer Low, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled) and CDC-0449 oral suspension (labeled) in people with Healthy, run by Genentech, Inc..
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 14 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
PK (Max observed and time to max plasma concentrations, area under the plasma concentration-time curve, absolute bioavailability, total plasma clearance, vol of dist, plasma terminal phase half-life, cumulative % excretion in urine and feces [Part B]) (time frame: Until study discontinuation). 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 26 Jun 2017.