Chronic PainPhase 1NCT01103739
To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
A Phase 1 study testing PF-04531083 and simvastatin in people with Chronic Pain, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- PF-04531083 and simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young
- healthy
- male and female volunteers
Who cannot join
- Elderly
- Patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
Read the detailed description
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
- Conditions
- Chronic Pain
- Being tested
- PF-04531083, simvastatin
- Keywords
- pharmacokinetics, drug-drug interaction
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04531083Drug
PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
simvastatinDrug
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
PF-04531083Drug
PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
simvastatinDrug
Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Not described Receives: Drug: PF-04531083; Drug: simvastatin |
| cohort 2 | Experimental | Not described Receives: Drug: PF-04531083; Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
Measured: days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
Measured: days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
Measured: days 2, 4, 7, 11 and 14 of the study
Secondary outcomes (1)
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
Measured: days 1 and 15 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT01103739
- Sponsor's protocol ID
- B1351007
- Status last verified
- Jun 2010
- First submitted
- 26 Feb 2010
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Fixed Sequence Study To Investigate The Effect Of Multiple Doses Of PF-04531083 On Simvastatin And Simvastatin Acid Pharmacokinetics Following Single Dose Of Simvastatin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01103739
- Acronym / sponsor ID
- B1351007
- Conditions
- Chronic Pain
- Keywords
- pharmacokinetics, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Apr 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.
The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
Detailed description
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: PF-04531083, Drug: simvastatin |
| cohort 2 | Experimental | Drug: PF-04531083, Drug: simvastatin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- young
- healthy
- male and female volunteers
Key exclusion criteria (2 listed)
- Elderly
- Patients
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 |
|---|---|---|
| PF-04531083PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study. | Drug | cohort 1 |
| simvastatinSimvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. | Drug | cohort 1 |
| PF-04531083PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study. | Drug | cohort 2 |
| simvastatinSimvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. | Drug | cohort 2 |
Primary outcome
Pharmacokinetics of simvastatin. AUC, Cmax and half life.
Time frame: days 1 and 14 of study
Pharmacokinetics of simvastatin acid. AUC, Cmax and half life.
Time frame: days 1 and 14 of study
Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing
Time frame: days 2, 4, 7, 11 and 14 of the study
1 secondary outcome
safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events
Time frame: days 1 and 15 of the study
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 4 Jun 2010.
- 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 PF-04531083 and simvastatin in people with Chronic Pain, 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 3 inclusion and 2 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 4 Jun 2010. 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. 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 of simvastatin. AUC, Cmax and half life. (time frame: days 1 and 14 of study). The study lists 3 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 4 Jun 2010.