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

NCT ID: NCT01396161

Last Updated: 2016-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Phase 1 Multiple Doses Safety Pharmacokinetics Pharmacodynamics Healthy Volunteers Type 2 Diabetic Patients

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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30 mg PF-05175157 or Placebo QD

Group Type EXPERIMENTAL

PF-05175157 or Placebo

Intervention Type DRUG

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.

100 mg PF-05175157 or Placebo QD

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

Group Type EXPERIMENTAL

PF-05175157 or Placebo

Intervention Type DRUG

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.

200 mg PF-05175157 or Placebo QD

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

Group Type EXPERIMENTAL

PF-05175157 or Placebo

Intervention Type DRUG

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.

100 mg PF-05175157 or Placebo BID

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

Group Type EXPERIMENTAL

PF-05175157 or Placebo

Intervention Type DRUG

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.

xxx mg PF-05175157

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

Group Type EXPERIMENTAL

PF-05175157 or Placebo

Intervention Type DRUG

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.

Interventions

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PF-05175157 or Placebo

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.

Intervention Type DRUG

PF-05175157 or Placebo

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.

Intervention Type DRUG

PF-05175157 or Placebo

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.

Intervention Type DRUG

PF-05175157 or Placebo

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.

Intervention Type DRUG

PF-05175157 or Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Miami Research Associates

South Miami, Florida, United States

Site Status

MRA Clinical Research

South Miami, Florida, United States

Site Status

Pulmonary Physicians of South Florida

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731007&StudyName=A%20Study%20of%20PF-05175157%20in%20Healthy%20Volunteers%20and%20Type%202%20Diabetic%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1731007

Identifier Type: -

Identifier Source: org_study_id