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

Phase 1

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PF-05190457 or Placebo

• Registration Number: NCT01372163
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Study Start: 2011-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-22
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events as a measure of safety and tolerability.	8 weeks

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.	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.	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.	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.	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.	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.	2 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States