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Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 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 (unless local
regulations dictate a minimum age of 21 years). 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 30.5 kg/m2; and a total body weight of between 50 kg
and 100 kg 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 hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic,
or allergic disease (including drug allergies, but excluding untreated, symptomatic,
seasonal allergies at time of dosing).

- Any condition possibly affecting drug absorption.

- 12-lead ECG demonstrating QTcF >450 msec at Screening. If QTcF exceeds 450 msec, the
ECG should be repeated two more times and the average of the three QTcF values should
be used to determine the subject's eligibility.

NCT01117233
Pfizer
Completed
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429

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Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429
A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy
  • Drug: PF-04427429
    single intravenous infusion of 10 mg PF-04427429 or placebo
  • Drug: PF-04427429
    single intravenous infusion of 30 mg PF-04427429 or placebo
  • Drug: PF-04427429
    single intravenous infusion of 100 mg PF-04427429 or placebo
  • Drug: PF-04427429
    single intravenous infusion of 300 mg PF-04427429 or placebo
  • Drug: PF-04427429
    single intravenous infusion of 1000 mg PF-04427429 or placebo
  • Experimental: Single IV Dose 1
    Intervention: Drug: PF-04427429
  • Experimental: Single IV Dose 2
    Intervention: Drug: PF-04427429
  • Experimental: Single IV Dose 3
    Intervention: Drug: PF-04427429
  • Experimental: Single IV Dose 4
    Intervention: Drug: PF-04427429
  • Experimental: Single IV Dose 5
    Intervention: Drug: PF-04427429
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 50 years inclusive (unless local regulations dictate a minimum age of 21 years). 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 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg 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 hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption.
  • 12-lead ECG demonstrating QTcF >450 msec at Screening. If QTcF exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01117233
B0141002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

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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