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
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
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Edinburgh, United Kingdom, EH14 4AP
- Pfizer Investigational Site
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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 |
|---|---|
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Active Comparator: Intravenous: PF-05186462
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single intravenous infusion of 100 microgram
single oral administration of 100 microgram
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Active Comparator: Oral: PF-05186462
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single intravenous infusion of 100 microgram
single oral administration of 100 microgram
|
|
Active Comparator: Intravenous: PF-05089771
|
single intravenous infusion of 100 microgram of PF-05089771
single oral administration of 100 microgram PF-05089771
|
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Active Comparator: Oral: PF-05089771
|
single intravenous infusion of 100 microgram of PF-05089771
single oral administration of 100 microgram PF-05089771
|
|
Active Comparator: Intravenous: PF-05150122
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single intravenous administration of 100 microgram PF-05150122
single oral administration of 100 microgram PF-05150122
|
|
Active Comparator: Oral: PF-05150122
|
single intravenous administration of 100 microgram PF-05150122
single oral administration of 100 microgram PF-05150122
|
|
Active Comparator: Intravenous: PF-05241328
|
single intravenous infusion of 100 microgram PF-05241328
single oral administration 100 microgram PF-05241328
|
|
Active Comparator: Oral: PF-05241328
|
single intravenous infusion of 100 microgram 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
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up to 3 days post dose
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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
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up to 3 days post dose
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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
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.
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.