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A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
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
18-50 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. (healthy is
defined as non 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 50 to 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

NCT01165723
Pfizer
Completed
A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated

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A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
Biological: PF-04427429
Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
  • Experimental: IV Dose 1: experimental
    Intervention: Biological: PF-04427429
  • Experimental: IV Dose 2: experimental
    Intervention: Biological: 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
21
January 2012
January 2012   (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 non 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 50 to 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 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01165723
B0141007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 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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