Diabetes Mellitus, Type 2Phase 1NCT01274663
A Study Of PF-05175157 In Healthy Volunteers
A Phase 1 study of Diabetes Mellitus, Type 2, run by Pfizer at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests.
- In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
- Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 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).
- 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 0.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
- Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.
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 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- PF-05175157 or Placebo
- Keywords
- Single Ascending Dose, Phase 1, Safety and Tolerability, PK, 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-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
PF-05175157 or PlaceboDrug
One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
| Study group | Role | What they receive |
|---|---|---|
| 10 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| 30 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| 100 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| 300 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| 600 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| 800 mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
| xxx mg PF-05175157 or Placebo | Experimental | Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. Receives: Drug: PF-05175157 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
Measured: 5 months
Single dose pharmacokinetics of PF-05175157
Measured: 5 months
Secondary outcomes (1)
Exploratory pharmacodynamic biomarkers
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 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
- NCT01274663
- Sponsor's protocol ID
- B1731001
- Status last verified
- Oct 2011
- First submitted
- 10 Jan 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01274663
- Acronym / sponsor ID
- B1731001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jan 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 evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 10 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 30 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 100 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 300 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 600 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| 800 mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
| xxx mg PF-05175157 or Placebo | Experimental | Drug: PF-05175157 or PlaceboSubjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests.
- In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
- Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- 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 0.
- Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
- Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.
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-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 10 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 30 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 100 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 300 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 600 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM. | Drug | 800 mg PF-05175157 or Placebo |
| PF-05175157 or PlaceboOne dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast. | Drug | xxx mg PF-05175157 or Placebo |
Primary outcome
Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
Time frame: 5 months
Single dose pharmacokinetics of PF-05175157
Time frame: 5 months
1 secondary outcome
Exploratory pharmacodynamic biomarkers
Time frame: 5 months
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 12 Oct 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 of 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 5 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 12 Oct 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 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?
Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects (time frame: 5 months). 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 12 Oct 2011.