A Study Of PF-05175157 In Healthy Volunteers - Full Text View

Purpose

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: PF-05175157 or Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Single dose pharmacokinetics of PF-05175157 [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exploratory pharmacodynamic biomarkers [ Time Frame: 5 months ] [ Designated as safety issue: No ]


Enrollment:	63
Study Start Date:	November 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274663

Locations


United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01274663 History of Changes
Other Study ID Numbers:	B1731001
Study First Received:	January 10, 2011
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2016