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A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients

Last updated on March 14, 2019

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Study Location
Miami Research Associates
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
examination.

- Body Mass Index (BMI) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

- Women must be of non-childbearing potential.

- Subjects with type 2 diabetes: HbA1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5%
and ≤9.0% if patient requires to be washed-off an SU or DPP-4i.

- For subjects with type 2 diabetes, due to possible effects on disposition, CYP P450
3A4/5 and 2D6 substrates should not be co-administered with study medications.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
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 within 3 months of Screening, or positive cotinine test
at Screening or Day -3.

- Active ocular disease including infection, glaucoma, seasonal allergies, dry eye
symptoms or retinal/optic nerve disease.

NCT01396161
Pfizer
Completed
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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