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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.

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: 15 mg PF-04995274
Drug: 10 mg PF-04995274
Drug: 1.0 mg PF-04995274
Drug: 0.1 mg PF-04995274
Drug: 1 mg PF-04995274

Study type

Interventional

Funder types

Industry

Identifiers

NCT01169714
B1661003

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

60 participants in 2 patient groups

Dosing Healthy Adult
Experimental group
Description:
Ascending Doses in Healthy Adult Volunteers
Treatment:
Drug: 1 mg PF-04995274
Drug: 0.1 mg PF-04995274
Drug: 15 mg PF-04995274
Drug: 10 mg PF-04995274
Drug: 15 mg PF-04995274
Dosing Healthy Elderly
Experimental group
Description:
Dosing in Healthy Elderly volunteers
Treatment:
Drug: 1.0 mg PF-04995274
Drug: 15 mg PF-04995274
Drug: 15 mg PF-04995274

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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