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

Pfizer

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Conditions

Healthy

Interventions

PF-03382792 0.5mgDRUG

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

PF-03382792 1.5 mgDRUG

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

PF-03382792 5 mgDRUG

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety Endpoints include: AEs, vital signs, triplicate ECGs,

Time frame: Day 0 to Day 28

Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations

Time frame: Day 0 to Day 28

Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),

Time frame: Day 0 to Day 28

Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.

Time frame: Day 0 to Day 28

Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.

Time frame: Day 0 to Day 28

Data from ClinicalTrials.gov

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