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Clinical Trial Details

Trial ID: L3426
Source ID: NCT01372163
Associated Drug: Pf-05190457 Or Placebo
Title: A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo|DRUG: PF-05190457 or Placebo
Outcome Measures: Primary: Number of participants with Adverse Events as a measure of safety and tolerability., 8 weeks | Secondary: 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
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 35
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-07
Completion Date: 2012-04
Results First Posted:
Last Update Posted: 2012-05-23
Locations: Pfizer Investigational Site, New Haven, Connecticut, 06511, United States
URL: https://clinicaltrials.gov/show/NCT01372163