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Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

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NCT01012310

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
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 Volunteers
Sex
Females and Males
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 and/or female subjects btween the ages of 18-55 years

- Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110
lbs).

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

- Evidence or history of clinically signifcant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 21 drinks/week within 6 months of
screening

- Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.

- Pregnant or nursing females; females of childbearing potentioal who are unwilling or
unable to use an acceptable method on contraception.

NCT01012310
Pfizer
Completed
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

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[email protected]

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Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
  • Experimental: Cohort 1
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 2
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 3
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 4
    Intervention: Drug: PF-04531083 or Placebo
Not Provided


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

Inclusion Criteria:

  • Healthy male and/or female subjects btween the ages of 18-55 years
  • Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
  • Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01012310
B1351002
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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.

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1-800-718-1021

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[email protected]



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