A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

Overview

This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.

Full Title of Study: “An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2010

Detailed Description

To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.

Interventions

  • Drug: 0.1 mg PF-04995274
    • 0.1 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 1 mg PF-04995274
    • 1 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 10 mg PF-04995274
    • 10 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 15 mg PF-04995274
    • 15 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 1.0 mg PF-04995274
    • 1.0 mg PF-04995274, qd, for 14 days or placebo
  • Drug: 15 mg PF-04995274
    • 15 mg PF-04995274, qd, for 14 days or placebo

Arms, Groups and Cohorts

  • Experimental: Dosing Healthy Adult
    • Ascending Doses in Healthy Adult Volunteers
  • Experimental: Dosing Healthy Elderly
    • Dosing in Healthy Elderly volunteers

Clinical Trial Outcome Measures

Primary Measures

  • Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST))
    • Time Frame: Day 0 to Day 28
  • Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2).
    • Time Frame: Day 0 to Day 28
  • Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects.
    • Time Frame: Day 0 to Day 14

Secondary Measures

  • No secondary outcomes

Participating in This Clinical Trial

Inclusion Criteria

  • For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
  • For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age.

Exclusion Criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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