A Study Of PF-05175157 In Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01274663 |
Recruitment Status
:
Completed
First Posted
: January 11, 2011
Last Update Posted
: October 12, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: PF-05175157 or Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: 10 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: 30 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: 100 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: 300 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: 600 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: 800 mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
|
Experimental: xxx mg PF-05175157 or Placebo
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
|
Drug: PF-05175157 or Placebo
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.
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- 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 ]
- Exploratory pharmacodynamic biomarkers [ Time Frame: 5 months ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274663
United States, Florida | |
Pfizer Investigational Site | |
South Miami, Florida, United States, 33143 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01274663 History of Changes |
Other Study ID Numbers: |
B1731001 |
First Posted: | January 11, 2011 Key Record Dates |
Last Update Posted: | October 12, 2011 |
Last Verified: | October 2011 |
Keywords provided by Pfizer:
Single Ascending Dose Phase 1 Safety and Tolerability PK Healthy Subjects |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |