NCT01372163
Terminated
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- PF-05190457 or Placebo
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Pfizer
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse Events as a measure of safety and tolerability.
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Arms & Interventions
2 mg PF-05190457 or Placebo BID
Intervention: PF-05190457 or Placebo
5 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Intervention: PF-05190457 or Placebo
10 mg PF-05190457 or Placebo BID
Intervention: PF-05190457 or Placebo
40 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Intervention: PF-05190457 or Placebo
150 mg PF-05190457 or Placebo BID
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Intervention: PF-05190457 or Placebo
50 mg PF-05190457 or Placebo QD
Dose and dose frequency may be adjusted based on emerging safety and PK data.
Intervention: PF-05190457 or Placebo
xxx mg PF-05190457 or Placebo
Dose and dose frequency to be determined based on emerging safety and PK data.
Intervention: PF-05190457 or Placebo
Outcomes
Primary Outcomes
Number of participants with Adverse Events as a measure of safety and tolerability.
Time Frame: 8 weeks
Secondary Outcomes
- 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)
Study Sites (1)
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