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
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