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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

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NCT01165736

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Edinburgh, , EH14 4AP United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01165736
Pfizer
Completed
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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05186462
    single intravenous infusion of 100 microgram
  • Drug: PF-05186462
    single oral administration of 100 microgram
  • Drug: PF-05089771
    single intravenous infusion of 100 microgram of PF-05089771
  • Drug: PF-05089771
    single oral administration of 100 microgram PF-05089771
  • Drug: PF-05150122
    single intravenous administration of 100 microgram PF-05150122
  • Drug: PF-05150122
    single oral administration of 100 microgram PF-05150122
  • Drug: PF-05241328
    single intravenous infusion of 100 microgram PF-05241328
  • Drug: PF-05241328
    single oral administration 100 microgram PF-05241328
  • Active Comparator: Intravenous: PF-05186462
    Intervention: Drug: PF-05186462
  • Active Comparator: Oral: PF-05186462
    Intervention: Drug: PF-05186462
  • Active Comparator: Intravenous: PF-05089771
    Intervention: Drug: PF-05089771
  • Active Comparator: Oral: PF-05089771
    Intervention: Drug: PF-05089771
  • Active Comparator: Intravenous: PF-05150122
    Intervention: Drug: PF-05150122
  • Active Comparator: Oral: PF-05150122
    Intervention: Drug: PF-05150122
  • Active Comparator: Intravenous: PF-05241328
    Intervention: Drug: PF-05241328
  • Active Comparator: Oral: PF-05241328
    Intervention: Drug: PF-05241328
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01165736
B3071001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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