To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

August 23, 2010 updated by: Pfizer

An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects

The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH14 4AP
        • Pfizer Investigational Site

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
  • Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

  • Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
  • History of febrile illness within 5 days prior to the first dose a positive urine drug screen

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous: PF-05186462
Drug: PF-05186462
single intravenous infusion of 100 microgram
Drug: PF-05186462
single oral administration of 100 microgram
Active Comparator: Oral: PF-05186462
Drug: PF-05186462
single intravenous infusion of 100 microgram
Drug: PF-05186462
single oral administration of 100 microgram
Active Comparator: Intravenous: PF-05089771
Drug: PF-05089771
single intravenous infusion of 100 microgram of PF-05089771
Drug: PF-05089771
single oral administration of 100 microgram PF-05089771
Active Comparator: Oral: PF-05089771
Drug: PF-05089771
single intravenous infusion of 100 microgram of PF-05089771
Drug: PF-05089771
single oral administration of 100 microgram PF-05089771
Active Comparator: Intravenous: PF-05150122
Drug: PF-05150122
single intravenous administration of 100 microgram PF-05150122
Drug: PF-05150122
single oral administration of 100 microgram PF-05150122
Active Comparator: Oral: PF-05150122
Drug: PF-05150122
single intravenous administration of 100 microgram PF-05150122
Drug: PF-05150122
single oral administration of 100 microgram PF-05150122
Active Comparator: Intravenous: PF-05241328
Drug: PF-05241328
single intravenous infusion of 100 microgram PF-05241328
Drug: PF-05241328
single oral administration 100 microgram PF-05241328
Active Comparator: Oral: PF-05241328
Drug: PF-05241328
single intravenous infusion of 100 microgram PF-05241328
Drug: PF-05241328
single oral administration 100 microgram PF-05241328

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)
Time Frame: up to 3 days post dose
up to 3 days post dose
pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve
Time Frame: up to 3 days post dose
up to 3 days post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)
Time Frame: up to 3 days post dose
up to 3 days post dose

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

July 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3071001

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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