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.

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 0.1 mg PF-04995274; Drug: 1 mg PF-04995274; Drug: 10 mg PF-04995274; Drug: 15 mg PF-04995274; Drug: 1.0 mg PF-04995274

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Pfizer Investigational Site
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing Healthy Adult; Ascending Doses in Healthy Adult Volunteers	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
Experimental: Dosing Healthy Elderly; Dosing in Healthy Elderly volunteers	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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))	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).	Day 0 to Day 28
Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects.	Day 0 to Day 14

Secondary Outcome Measures

Outcome Measure
No secondary outcomes

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 26, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2011
• Last Update Submitted That Met QC Criteria: January 19, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: safety; healthy volunteer; pharmacokinetic; multiple dose; healthy elderly volunteer
• Other Study ID Numbers: B1661003