Type 2 Diabetes MellitusPhase 1NCT01469468
A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
A Phase 1 study testing Simvastatin and PF-05175157 in people with Type 2 Diabetes Mellitus, run by Pfizer at 1 site in United States.
Trial summary
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Simvastatin and PF-05175157
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Known history of intolerance to simvastatin or other statins.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Simvastatin, PF-05175157
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
PF-05175157Drug
Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Single arm, fixed sequence dosing | Experimental | Not described Receives: Drug: Simvastatin; Drug: PF-05175157 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration curve of simvastatin and simvastatin acid
Measured: 10 days
Maximum observed plasma concentration of simvastatin and simvastatin acid
Measured: 10 days
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
Measured: 10 days
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
Measured: 10 days
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 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 Type 2 Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469468
- Sponsor's protocol ID
- B1731012
- Status last verified
- Nov 2018
- First submitted
- 29 Oct 2011
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01469468
- Acronym / sponsor ID
- B1731012
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 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.
The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, fixed sequence dosing | Experimental | Drug: Simvastatin, Drug: PF-05175157 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects with normal results in all screening examinations.
- Body Mass Index of 17.5 to 35.5 kg/m2
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Known history of intolerance to simvastatin or other statins.
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 |
|---|---|---|
| SimvastatinDay 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157) | Drug | Single arm, fixed sequence dosing |
| PF-05175157Days 2-9 inclusive: daily dosing of PF-05175157 200 mg | Drug | Single arm, fixed sequence dosing |
Primary outcome
Area under the plasma concentration curve of simvastatin and simvastatin acid
Time frame: 10 days
Maximum observed plasma concentration of simvastatin and simvastatin acid
Time frame: 10 days
Time at which maximum plasma concentration of simvastatin and simvastatin acid is observed
Time frame: 10 days
If the data permit, area under the plasma concentration curve of simvastatin and simvastatin acid extrapolated to infinite time
Time frame: 10 days
If the data permit, terminal elimination half-life of simvastatin and simvastatin acid
Time frame: 10 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 14 Nov 2018.
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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 Simvastatin and PF-05175157 in people with Type 2 Diabetes Mellitus, run by Pfizer 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 2 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 14 Nov 2018. 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?
Area under the plasma concentration curve of simvastatin and simvastatin acid (time frame: 10 days). The study lists 5 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 14 Nov 2018.