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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396161
• Other study ID #: B1731007
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2011
• Last updated: February 20, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 weeks	Yes
Secondary	Single dose and steady state pharmacokinetics of PF 05175157 by estimating maximal concentration [Cmax]		2 weeks	No
Secondary	Single dose and steady state pharmacokinetics of PF 05175157 by estimating time of maximum concentration [Tmax]		2 weeks	No
Secondary	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)]		2 weeks	No
Secondary	As data permit, t1/2 in plasma for PF-05175157		2 weeks	No
Secondary	Urinary recovery and renal clearance of PF 05175157		2 weeks	No

External Links

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