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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396161
First received: June 20, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-05175157 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Oral Doses Of PF-05175157 In Healthy Volunteers And In Patients With Type 2 Diabetes Mellitus (T2DM)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability endpoints: Safety and tolerability assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital signs, clinical safety laboratory measurements, pulmonary function testing and ocular examinations. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Single dose and steady state pharmacokinetics of PF 05175157 by estimating maximal concentration [Cmax] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Single dose and steady state pharmacokinetics of PF 05175157 by estimating time of maximum concentration [Tmax] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Single dose and steady state pharmacokinetics of PF 05175157 by estimating areas under the curve [AUC(0-t)] and accumulation ratios [Rac (AUC(t,ss)/AUC(t,sd)] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • As data permit, t1/2 in plasma for PF-05175157 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Urinary recovery and renal clearance of PF 05175157 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30 mg PF-05175157 or Placebo QD 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.
Experimental: 100 mg PF-05175157 or Placebo QD
Planned dose might be modified based on emerging safety and PK data.
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.
Experimental: 200 mg PF-05175157 or Placebo QD
Planned dose might be modified based on emerging safety and PK data.
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.
Experimental: 100 mg PF-05175157 or Placebo BID
Planned dose might be modified based on emerging safety and PK data.
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.
Experimental: xxx mg PF-05175157
Dose will be determined based on results obtained from Arms 1 to 4.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396161

Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396161     History of Changes
Other Study ID Numbers: B1731007
Study First Received: June 20, 2011
Last Updated: February 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Multiple Doses
Safety
Pharmacokinetics
Pharmacodynamics
Healthy Volunteers
Type 2 Diabetic Patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014