Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects



Status:Completed
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:5/27/2013
Start Date:May 2013
End Date:June 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects


This study is designed to assess the safety, tolerability and pharmacokinetics of multiple
oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight
and obese subjects.


Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:

- 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).

- Women must be of non childbearing potential.

- Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight >50 kg
(110 lbs).

- An informed consent document signed and dated by the subject.

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
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 and a history of smoking more than 10 pack
years, or history or evidence of habitual use of other (non smoked) tobacco or
nicotine containing products. Active ocular disease including infection, glaucoma,
seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
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