FibromyalgiaPhase 1TQTNCT00809289
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
A Phase 1 study testing esreboxetine and moxifloxacin in people with Fibromyalgia, run by Pfizer at 1 site in Belgium.
Trial summary
This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- esreboxetine and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2008to Jul 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 18 to 55 years
- Body mass Index of approximately 18 to 30kg/m2
- Informed consent document signed by the subject or a legally acceptable representative
- Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures
Who cannot join
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
- Conditions possibly affecting drug absorption
- 12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen
- Positive urine drug screen
- Hypersensitivity to moxifloxacin
- Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
- Conditions
- Fibromyalgia
- Being tested
- esreboxetine, placebo, moxifloxacin
- Keywords
- Thorough QT/QTc study
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esreboxetineDrug
Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind.
placeboDrug
Once daily administration of placebo for 9 days. Placebo will be administered double blind
moxifloxacinDrug
Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9
| Study group | Role | What they receive |
|---|---|---|
| One | Experimental | Not described Receives: Drug: esreboxetine |
| Two | Placebo comparator | Not described Receives: Drug: placebo |
| Three | Active comparator | Administration of a single oral dse of 400mg moxifloxacin Receives: Drug: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
Measured: Up to 24 hours
Secondary outcomes (2)
To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval
Measured: Up to 24 hours
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809289
- Sponsor's protocol ID
- A6061065
- Acronym
- TQT
- Status last verified
- Apr 2011
- First submitted
- 16 Dec 2008
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00809289
- Acronym / sponsor ID
- TQT / A6061065
- Conditions
- Fibromyalgia
- Keywords
- Thorough QT/QTc study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Dec 2008 (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 Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One | Experimental | Drug: esreboxetine |
| Two | Placebo comparator | Drug: placebo |
| Three | Active comparator | Drug: moxifloxacinAdministration of a single oral dse of 400mg moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects aged 18 to 55 years
- Body mass Index of approximately 18 to 30kg/m2
- Informed consent document signed by the subject or a legally acceptable representative
- Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures
Key exclusion criteria (6 listed)
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
- Conditions possibly affecting drug absorption
- 12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen
- Positive urine drug screen
- Hypersensitivity to moxifloxacin
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 |
|---|---|---|
| esreboxetineOnce daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind. | Drug | One |
| placeboOnce daily administration of placebo for 9 days. Placebo will be administered double blind | Drug | Two |
| moxifloxacinOnce daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9 | Drug | Three |
Primary outcome
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
Time frame: Up to 24 hours
2 secondary outcomes
To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval
Time frame: Up to 24 hours
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
Time frame: Up to 24 hours
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 7 Apr 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 esreboxetine and moxifloxacin in people with Fibromyalgia, run by Pfizer at 1 site in Belgium.
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 6 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 7 Apr 2011. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers (time frame: Up to 24 hours). 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 7 Apr 2011.