HealthyPhase 1NCT01821079
A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation
A Phase 1 study testing PF-05175157 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-05175157
- 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 siteUnited States
- Study dates
- Mar 2013to Apr 2013
- 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, inclusive
- Women must be of non childbearing potential
- Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight >50 kg (110 lbs)
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
- History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers
The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.
- Conditions
- Healthy
- Being tested
- PF-05175157
- Keywords
- Single dose, Relative Bioavailability, Food effect, Healthy subjects, Diabetes Mellitus Type 2
- 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-05175157Drug
Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)
PF-05175157Drug
Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
PF-05175157Drug
Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
PF-05175157Drug
Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
| Study group | Role | What they receive |
|---|---|---|
| PF-05175157 PIC in fed state | Experimental | 200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal). Receives: Drug: PF-05175157 |
| PF-05175157 tablet in fed state | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). Receives: Drug: PF-05175157 |
| PF-05175157 tablet in fed state (repeat) | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). Receives: Drug: PF-05175157 |
| PF-05175157 tablet in fasted state | Experimental | 200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast). Receives: Drug: PF-05175157 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 0 to 72 H after dose
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Measured: 0 to 72 H after dose
Secondary outcomes (3)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0 to 72 H after dose
Time at which maximum plasma concentration is observed (Tmax)
Measured: 0 to 72 H after dose
Plasma Decay Half-Life (t1/2)
Measured: 0 to 72 H after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821079
- Sponsor's protocol ID
- B1731014
- Status last verified
- May 2013
- First submitted
- 26 Mar 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01821079
- Acronym / sponsor ID
- B1731014
- Conditions
- Healthy
- Keywords
- Single dose, Relative Bioavailability, Food effect, Healthy subjects, Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Mar 2013 (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 in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PF-05175157 PIC in fed state | Experimental | Drug: PF-05175157200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fed state | Experimental | Drug: PF-05175157200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fed state (repeat) | Experimental | Drug: PF-05175157200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). |
| PF-05175157 tablet in fasted state | Experimental | Drug: PF-05175157200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
- Women must be of non childbearing potential
- Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight >50 kg (110 lbs)
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
- History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0
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-05175157Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg) | Drug | PF-05175157 PIC in fed state |
| PF-05175157Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) | Drug | PF-05175157 tablet in fed state |
| PF-05175157Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) | Drug | PF-05175157 tablet in fed state (repeat) |
| PF-05175157Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg) | Drug | PF-05175157 tablet in fasted state |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 to 72 H after dose
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: 0 to 72 H after dose
3 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0 to 72 H after dose
Time at which maximum plasma concentration is observed (Tmax)
Time frame: 0 to 72 H after dose
Plasma Decay Half-Life (t1/2)
Time frame: 0 to 72 H after 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 21 May 2013.
- 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-05175157 in people with Healthy, 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 3 inclusion and 3 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 21 May 2013. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0 to 72 H after dose). 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 21 May 2013.