A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-01

Study Completion Date

2011-04-25

Brief Summary

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This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.

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Detailed Description

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To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dosing

Ascending Doses

Group Type EXPERIMENTAL

PF-03382792 0.5mg

Intervention Type DRUG

0.5 mg PF-03382792, qd, for 14 days or placebo

PF-03382792 1.5 mg

Intervention Type DRUG

1.5 mg PF-03382792, qd, for 14 days or placebo

PF-03382792 5 mg

Intervention Type DRUG

5 mg PF-03382792, qd, for 14 days or placebo

PF-03382792 15 mg

Intervention Type DRUG

15 mg PF-03382792, qd, for 14 days or placebo

Interventions

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PF-03382792 0.5mg

0.5 mg PF-03382792, qd, for 14 days or placebo

Intervention Type DRUG

PF-03382792 1.5 mg

1.5 mg PF-03382792, qd, for 14 days or placebo

Intervention Type DRUG

PF-03382792 5 mg

5 mg PF-03382792, qd, for 14 days or placebo

Intervention Type DRUG

PF-03382792 15 mg

15 mg PF-03382792, qd, for 14 days or placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer aged 65-80 years old
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
* Total body weight \>50 kg (110 lbs).

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).
* Subjects with symptoms or signs of adrenal insufficiency.
* Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes