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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

NCT ID: NCT01165736

Last Updated: 2010-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intravenous: PF-05186462

Group Type ACTIVE_COMPARATOR

PF-05186462

Intervention Type DRUG

single intravenous infusion of 100 microgram

Oral: PF-05186462

Group Type ACTIVE_COMPARATOR

PF-05186462

Intervention Type DRUG

single oral administration of 100 microgram

Intravenous: PF-05089771

Group Type ACTIVE_COMPARATOR

PF-05089771

Intervention Type DRUG

single intravenous infusion of 100 microgram of PF-05089771

Oral: PF-05089771

Group Type ACTIVE_COMPARATOR

PF-05089771

Intervention Type DRUG

single oral administration of 100 microgram PF-05089771

Intravenous: PF-05150122

Group Type ACTIVE_COMPARATOR

PF-05150122

Intervention Type DRUG

single intravenous administration of 100 microgram PF-05150122

Oral: PF-05150122

Group Type ACTIVE_COMPARATOR

PF-05150122

Intervention Type DRUG

single oral administration of 100 microgram PF-05150122

Intravenous: PF-05241328

Group Type ACTIVE_COMPARATOR

PF-05241328

Intervention Type DRUG

single intravenous infusion of 100 microgram PF-05241328

Oral: PF-05241328

Group Type ACTIVE_COMPARATOR

PF-05241328

Intervention Type DRUG

single oral administration 100 microgram PF-05241328

Interventions

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PF-05186462

single intravenous infusion of 100 microgram

Intervention Type DRUG

PF-05186462

single oral administration of 100 microgram

Intervention Type DRUG

PF-05089771

single intravenous infusion of 100 microgram of PF-05089771

Intervention Type DRUG

PF-05089771

single oral administration of 100 microgram PF-05089771

Intervention Type DRUG

PF-05150122

single intravenous administration of 100 microgram PF-05150122

Intervention Type DRUG

PF-05150122

single oral administration of 100 microgram PF-05150122

Intervention Type DRUG

PF-05241328

single intravenous infusion of 100 microgram PF-05241328

Intervention Type DRUG

PF-05241328

single oral administration 100 microgram PF-05241328

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3071001&StudyName=To%20calculate%20the%20pharmacokinetics%20%28concentration%20of%20compound%20in%20and%20rate%20of%20excretion%20from%20the%20blood%29%20following%20a%20very%20low%20dose%20of

To obtain contact information for a study center near you, click here.

Other Identifiers

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B3071001

Identifier Type: -

Identifier Source: org_study_id

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