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.
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01169714
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing Healthy Adult 0.1 mg PF-04995274 Ascending Doses in Healthy Adult Volunteers Dosing Healthy Adult 1 mg PF-04995274 Ascending Doses in Healthy Adult Volunteers Dosing Healthy Adult 10 mg PF-04995274 Ascending Doses in Healthy Adult Volunteers Dosing Healthy Adult 15 mg PF-04995274 Ascending Doses in Healthy Adult Volunteers Dosing Healthy Elderly 1.0 mg PF-04995274 Dosing in Healthy Elderly volunteers Dosing Healthy Elderly 15 mg PF-04995274 Dosing in Healthy Elderly volunteers
- Primary Outcome Measures
Name Time Method 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
Name Time Method No secondary outcomes
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Overland Park, Kansas, United States