Diabetes Mellitus, Type 2Phase 1NCT01537497
A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers
A Phase 1 study testing PF-05175157 in people with Diabetes Mellitus, Type 2, run by Pfizer at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers 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-05175157
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2012
- 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.
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
- Women must be of non-childbearing potential.
- Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
- Evidence or history of any chronic ongoing or current pulmonary disease.
- History of 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 -7.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-05175157, Placebo
- Keywords
- Phase 1, Single Doses, Pharmacodynamics, 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-05175157Drug
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
PF-05175157Drug
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
PF-05175157Drug
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
PlaceboDrug
One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
| Study group | Role | What they receive |
|---|---|---|
| 100 mg PF-05175157 | Experimental | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. Receives: Drug: PF-05175157 |
| 250 mg PF-05175157 | Experimental | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. Receives: Drug: PF-05175157 |
| 600 mg PF-05175157 | Experimental | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. Receives: Drug: PF-05175157 |
| Placebo | Placebo comparator | The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of carbohydrate and lipid metabolism
Measured: 24 hours
Secondary outcomes (3)
Cmax of PF-05175157 after single oral doses
Measured: 24 hours
Tmax of PF-05175157 after single oral doses
Measured: 24 hours
Area under the curve (AUC) of PF-05175157 after single oral doses
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionMay 2012
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 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
- NCT01537497
- Sponsor's protocol ID
- B1731013
- Status last verified
- Jul 2012
- First submitted
- 17 Feb 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01537497
- Acronym / sponsor ID
- B1731013
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Phase 1, Single Doses, Pharmacodynamics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 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 primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100 mg PF-05175157 | Experimental | Drug: PF-05175157The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| 250 mg PF-05175157 | Experimental | Drug: PF-05175157The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| 600 mg PF-05175157 | Experimental | Drug: PF-05175157The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
| Placebo | Placebo comparator | Drug: PlaceboThe chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
- Women must be of non-childbearing potential.
- Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
- Evidence or history of any chronic ongoing or current pulmonary disease.
- History of 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 -7.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve 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-05175157One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM. | Drug | 100 mg PF-05175157 |
| PF-05175157One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM. | Drug | 250 mg PF-05175157 |
| PF-05175157One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM. | Drug | 600 mg PF-05175157 |
| PlaceboOne single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM. | Drug | Placebo |
Primary outcome
Modulation of carbohydrate and lipid metabolism
Time frame: 24 hours
3 secondary outcomes
Cmax of PF-05175157 after single oral doses
Time frame: 24 hours
Tmax of PF-05175157 after single oral doses
Time frame: 24 hours
Area under the curve (AUC) of PF-05175157 after single oral doses
Time frame: 24 hours
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 10 Jul 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-05175157 in people with Diabetes Mellitus, Type 2, 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 4 inclusion and 4 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 10 Jul 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 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. Some participants in this study may receive a placebo. 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?
Modulation of carbohydrate and lipid metabolism (time frame: 24 hours). 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 10 Jul 2012.