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
Overview
- Phase
- Phase 1
- Intervention
- 0.1 mg PF-04995274
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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))
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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).
Arms & Interventions
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
Intervention: 0.1 mg PF-04995274
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
Intervention: 1 mg PF-04995274
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
Intervention: 10 mg PF-04995274
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
Intervention: 15 mg PF-04995274
Dosing Healthy Elderly
Dosing in Healthy Elderly volunteers
Intervention: 1.0 mg PF-04995274
Dosing Healthy Elderly
Dosing in Healthy Elderly volunteers
Intervention: 15 mg PF-04995274
Outcomes
Primary Outcomes
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 Outcomes
- No secondary outcomes