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

An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01089738

Enrollment

Registered

2010-03-18

Start date

2010-11-01

Completion date

2011-04-25

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

mulitple dose, pharmacokinetics, safety, healthy elderly volunteers

Brief summary

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.

Detailed description

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

Interventions

DRUGPF-03382792 0.5mg

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

DRUGPF-03382792 1.5 mg

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

DRUGPF-03382792 5 mg

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

DRUGPF-03382792 15 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety Endpoints include: AEs, vital signs, triplicate ECGs,	Day 0 to Day 28
Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations	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),	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.	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.	Day 0 to Day 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026