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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dosing Healthy Adult

Ascending Doses in Healthy Adult Volunteers

Group Type EXPERIMENTAL

0.1 mg PF-04995274

Intervention Type DRUG

0.1 mg PF-04995274, qd, for 14 days or placebo

1 mg PF-04995274

Intervention Type DRUG

1 mg PF-04995274, qd, for 14 days or placebo

10 mg PF-04995274

Intervention Type DRUG

10 mg PF-04995274, qd, for 14 days or placebo

15 mg PF-04995274

Intervention Type DRUG

15 mg PF-04995274, qd, for 14 days or placebo

Dosing Healthy Elderly

Dosing in Healthy Elderly volunteers

Group Type EXPERIMENTAL

1.0 mg PF-04995274

Intervention Type DRUG

1.0 mg PF-04995274, qd, for 14 days or placebo

15 mg PF-04995274

Intervention Type DRUG

15 mg PF-04995274, qd, for 14 days or placebo

Interventions

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0.1 mg PF-04995274

0.1 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

1 mg PF-04995274

1 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

10 mg PF-04995274

10 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

15 mg PF-04995274

15 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

1.0 mg PF-04995274

1.0 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

15 mg PF-04995274

15 mg PF-04995274, qd, for 14 days or placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes