Diabetes Mellitus, Type 2Phase 1NCT01366287
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
A Phase 1 study testing PF-03882845 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in Belgium.
Trial summary
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PF-03882845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Feb 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 male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Serum potassium >5 mEq/L at screening.
- Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-03882845
- Keywords
- Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects
- 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.
PF-03882845Drug
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
PF-03882845Drug
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
PF-03882845Drug
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Suspension/fasted | Experimental | Not described Receives: Drug: PF-03882845 |
| Tablet/fasted | Experimental | Not described Receives: Drug: PF-03882845 |
| Tablet/fed | Experimental | Not described Receives: Drug: PF-03882845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Post dose is measured at 24, 48 and 96 hours after dose.
Measured: predose and post each dose (24, 48 and 96 hour timepoints)
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 12 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
- NCT01366287
- Sponsor's protocol ID
- B0171006
- Status last verified
- Jun 2011
- First submitted
- 4 Jan 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01366287
- Acronym / sponsor ID
- B0171006
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Jun 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 primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspension/fasted | Experimental | Drug: PF-03882845 |
| Tablet/fasted | Experimental | Drug: PF-03882845 |
| Tablet/fed | Experimental | Drug: PF-03882845 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (2 listed)
- Serum potassium >5 mEq/L at screening.
- Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.
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-0388284525 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition | Drug | Suspension/fasted |
| PF-0388284525 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition | Drug | Tablet/fasted |
| PF-0388284525 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition | Drug | Tablet/fed |
Primary outcome
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Time frame: predose and post each dose (24, 48 and 96 hour timepoints)
Post dose is measured at 24, 48 and 96 hours after dose.
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Time frame: 45 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 6 Jun 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 PF-03882845 in people with Diabetes Mellitus, Type 2, 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 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 6 Jun 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. 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?
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit. (time frame: predose and post each dose (24, 48 and 96 hour timepoints)). The study lists 2 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 6 Jun 2011.