Diabetes Mellitus, Type 2Phase 1NCT01522807
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
A Phase 1 study testing PF-05190457 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- PF-05190457
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2011to Nov 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-05190457
- Keywords
- Phase 1, Single Doses, Biocomparison, Pharmacokinetics, Healthy Volunteers
- 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-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
PF-05190457Drug
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
| Study group | Role | What they receive |
|---|---|---|
| 100 mg PF-05190457 | Experimental | Three fasted treatments and fed with the short-duration osmotic capsule Receives: Drug: PF-05190457 |
| 100 mg PF - 05190457 | Experimental | Three fasted treatments and fed with the long-duration osmotic capsule Receives: Drug: PF-05190457 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
Measured: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
Measured: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
Measured: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
Measured: 0 - 48 hours post dose
Secondary outcomes (3)
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
Measured: 0 - 48 hours post dose
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
Measured: 0 - 48 hours post dose
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
Measured: 0 - 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 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
- NCT01522807
- Sponsor's protocol ID
- B3301007
- Status last verified
- Jan 2012
- First submitted
- 30 Oct 2011
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01522807
- Acronym / sponsor ID
- B3301007
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Phase 1, Single Doses, Biocomparison, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Feb 2012 (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 the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg PF-05190457 | Experimental | Drug: PF-05190457Three fasted treatments and fed with the short-duration osmotic capsule |
| 100 mg PF - 05190457 | Experimental | Drug: PF-05190457Three fasted treatments and fed with the long-duration osmotic capsule |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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-05190457100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state | Drug | 100 mg PF-05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state | Drug | 100 mg PF-05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state | Drug | 100 mg PF-05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state | Drug | 100 mg PF-05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state | Drug | 100 mg PF - 05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state | Drug | 100 mg PF - 05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state | Drug | 100 mg PF - 05190457 |
| PF-05190457100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state | Drug | 100 mg PF - 05190457 |
Primary outcome
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
Time frame: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
Time frame: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
Time frame: 0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
Time frame: 0 - 48 hours post dose
3 secondary outcomes
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
Time frame: 0 - 48 hours post dose
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
Time frame: 0 - 48 hours post dose
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
Time frame: 0 - 24 hours post dose
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 1 Feb 2012.
- 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-05190457 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in Singapore.
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 1 inclusion and 1 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 1 Feb 2012. 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 Singapore. 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?
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit. (time frame: 0 - 48 hours post dose). The study lists 4 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 1 Feb 2012.