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

November 3, 2018 updated by: Pfizer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dosing
Ascending Doses
Drug: PF-03382792 0.5mg
0.5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 1.5 mg
1.5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 5 mg
5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 15 mg
15 mg PF-03382792, qd, for 14 days or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Endpoints include: AEs, vital signs, triplicate ECGs,
Time Frame: Day 0 to Day 28
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
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
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
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
Day 0 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Anticipated)

April 25, 2011

Study Completion (Anticipated)

April 25, 2011

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 3, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1651003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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