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A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

This study has been terminated.
(B3301002 was discontinued on 18 April 2012 for strategic reasons.There were no safety concerns leading to discontinuation of this study.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01372163
First received: June 10, 2011
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: PF-05190457 or Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Doses Of PF-05190457 In Healthy And Type 2 Diabetic Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent total clearance of the drug from plasma after oral administration (CL/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) on days 13 and 14, as the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Urinary recovery and renal clearance of PF-05190457 will be estimated via comparison of the plasma AUC and urinary excretion to provide AE0-τ, AE0-τ%, and CLR as the data permit. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 mg PF-05190457 or Placebo BID Drug: PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
Experimental: 10 mg PF-05190457 or Placebo BID Drug: PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
Experimental: 40 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
 Drug: PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
Experimental: 150 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
 Drug: PF-05190457 or Placebo
Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
Experimental: 5 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
 Drug: PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
Experimental: 50 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
 Drug: PF-05190457 or Placebo
Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
Experimental: xxx mg PF-05190457 or Placebo
Dose and dose frequency to be determined based on emerging safety and PK data.
 Drug: PF-05190457 or Placebo
Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m^2, and weight between 50 and 100 kg, inclusive.
  • Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372163

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01372163     History of Changes
Other Study ID Numbers: B3301002
Study First Received: June 10, 2011
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Multiple Ascending Doses
Safety
 Pharmacokinetics
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 June 18, 2013