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

• ClinicalTrials.gov Identifier: NCT01372163
• Recruitment Status: Terminated
• First Posted: June 13, 2011
• Last Update Posted: May 23, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 10, 2011
• First Posted Date: June 13, 2011
• Last Update Posted Date: May 23, 2012
• Study Start Date: July 2011
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 3, 2011): Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures (submitted: June 10, 2011): Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: 4 weeks ]
• Change History: Complete list of historical versions of study NCT01372163 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 3, 2011)

• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]

Original Secondary Outcome Measures (submitted: June 10, 2011)

• 1. 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Diabetes Mellitus, Type 2

Intervention

• 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.
• 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.
• 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.

Study Arms

• Experimental: 2 mg PF-05190457 or Placebo BID
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: 10 mg PF-05190457 or Placebo BID
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: 40 mg PF-05190457 or Placebo BID
  Dose and dose frequency may be adjusted based on emerging safety and PK data.
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: 150 mg PF-05190457 or Placebo BID
  Dose and dose frequency may be adjusted based on emerging safety and PK data.
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: 5 mg PF-05190457 or Placebo QD
  Dose and dose frequency may be adjusted based on emerging safety and PK data.
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: 50 mg PF-05190457 or Placebo QD
  Dose and dose frequency may be adjusted based on emerging safety and PK data.
  Intervention: Drug: PF-05190457 or Placebo
• Experimental: xxx mg PF-05190457 or Placebo
  Dose and dose frequency to be determined based on emerging safety and PK data.
  Intervention: Drug: PF-05190457 or Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 16, 2012): 35
• Original Estimated Enrollment (submitted: June 10, 2011): 63
• Actual Study Completion Date: April 2012
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01372163
• Other Study ID Numbers: B3301002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2012