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.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01169714
First received: July 22, 2010
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Healthy
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects. [ Time Frame: Day 0 to Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcomes [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169714

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01169714     History of Changes
Other Study ID Numbers: B1661003
Study First Received: July 22, 2010
Last Updated: January 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
multiple dose
healthy volunteer
healthy elderly volunteer
safety
pharmacokinetic

ClinicalTrials.gov processed this record on July 23, 2014