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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: September 19, 2016
Last verified: September 2016
  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
Masking: Double Blind (Participant, 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)

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 2 weeks ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.


Secondary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
  • Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
    Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).

  • Renal Clearance (CLr) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
    CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.

  • Plasma Decay Half-Life (t1/2) [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Urinary Recovery [ Time Frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11 ]
    Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.


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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396161

Locations
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
MRA Clinical Research
South Miami, Florida, United States, 33143
Pulmonary Physicians of South Florida
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396161     History of Changes
Other Study ID Numbers: B1731007
Study First Received: June 20, 2011
Results First Received: April 1, 2016
Last Updated: September 19, 2016

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 May 25, 2017