Healthy VolunteerPhase 1NCT01173536
A Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
A Phase 1 study testing GDC-0449 and moxifloxacin in people with Healthy Volunteer, run by Genentech, Inc..
Trial summary
This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GDC-0449 and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2010to 18 Mar 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, over 45 years of age
- In good health, as determined by the absence of clinically significant findings from the screening visit
- Body mass index between 18 and 32 kg/m^2 inclusive, with a body weight > 45 kg
- Of non-childbearing potential
Who cannot join
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
- Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
- Personal or family history of congenital long QT syndrome or family history of sudden death
- Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study
About this study
Official title: A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
This is a Phase I, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.
- Conditions
- Healthy Volunteer
- Being tested
- GDC-0449, moxifloxacin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0449Drug
Oral repeating dose
moxifloxacinDrug
Oral single dose
placeboDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: moxifloxacin; Drug: placebo |
| B | Active comparator | Not described Receives: Drug: moxifloxacin; Drug: placebo |
| C | Experimental | Not described Receives: Drug: GDC-0449; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The QTcF (QT interval corrected by Fridericia's correction method)
Measured: Throughout study or until early discontinuation
Secondary outcomes (3)
Change in ECG from baseline
Measured: Throughout study or until early discontinuation
Pharmacokinetic parameters of GDC-0449
Measured: Throughout study or until early discontinuation
Incidence, nature and severity of adverse events
Measured: Throughout study or until early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study start25 Aug 2010
- Primary completion18 Mar 2011
- Study completion18 Mar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Ayache, M.D., Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173536
- Sponsor's protocol ID
- SHH4871g
- Status last verified
- Feb 2017
- First submitted
- 29 Jul 2010
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Active-Comparator, Parallel-Group Study to Investigate the Effect of GDC-0449 on the QT/QTc Interval in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01173536
- Acronym / sponsor ID
- SHH4871g
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2010 (actual)
- Primary completion
- 18 Mar 2011 (actual)
- Study completion
- 18 Mar 2011 (actual)
- First posted
- 2 Aug 2010 (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, single-center, three-arm, randomized, double-blind, active- and placebo-controlled study to investigate the effect of GDC-0449 on the QT/QTc interval in healthy female subjects of non-childbearing potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: moxifloxacin, Drug: placebo |
| B | Active comparator | Drug: moxifloxacin, Drug: placebo |
| C | Experimental | Drug: GDC-0449, Drug: placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, over 45 years of age
- In good health, as determined by the absence of clinically significant findings from the screening visit
- Body mass index between 18 and 32 kg/m^2 inclusive, with a body weight > 45 kg
- Of non-childbearing potential
Key exclusion criteria (4 listed)
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiac, vascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer; or cirrhosis
- Allergy to moxifloxacin or any quinolone antibiotics or any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
- Personal or family history of congenital long QT syndrome or family history of sudden death
- Participation in an investigational drug or device study with an investigational drug within the last 3 months or six times the elimination half-life, whichever is longer, prior to Day 1 of the study
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-0449Oral repeating dose | Drug | C |
| moxifloxacinOral single dose | Drug | A, B |
| placeboOral repeating dose | Drug | A, B, C |
Primary outcome
The QTcF (QT interval corrected by Fridericia's correction method)
Time frame: Throughout study or until early discontinuation
3 secondary outcomes
Change in ECG from baseline
Time frame: Throughout study or until early discontinuation
Pharmacokinetic parameters of GDC-0449
Time frame: Throughout study or until early discontinuation
Incidence, nature and severity of adverse events
Time frame: Throughout study or until early 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 17 Feb 2017.
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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.
Jean Ayache, M.D. study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0449 and moxifloxacin in people with Healthy Volunteer, 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 4 inclusion and 4 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 17 Feb 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?
The QTcF (QT interval corrected by Fridericia's correction method) (time frame: Throughout study or until early 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 17 Feb 2017.