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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: PF-05175157 or Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01396161

B1731007

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

64 participants in 5 patient groups

30 mg PF-05175157 or Placebo QD

Experimental group

Treatment:

Drug: PF-05175157 or Placebo

100 mg PF-05175157 or Placebo QD

Experimental group

Description:

Planned dose might be modified based on emerging safety and PK data.

Treatment:

Drug: PF-05175157 or Placebo

200 mg PF-05175157 or Placebo QD

Experimental group

Description:

Planned dose might be modified based on emerging safety and PK data.

Treatment:

Drug: PF-05175157 or Placebo

100 mg PF-05175157 or Placebo BID

Experimental group

Description:

Planned dose might be modified based on emerging safety and PK data.

Treatment:

Drug: PF-05175157 or Placebo

xxx mg PF-05175157

Experimental group

Description:

Dose will be determined based on results obtained from Arms 1 to 4.

Treatment:

Drug: PF-05175157 or Placebo

Trial contacts and locations

3

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