A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo
Intervention description: One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers.; One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Multiple Doses; Safety; Pharmacokinetics; Pharmacodynamics; Healthy Volunteers; Type 2 Diabetic Patients

Summary:

      The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics
      and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and
      patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

          -  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.