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A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- For Healthy adult volunteers: healthy male and/or female subjects of non child bearing
potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no
clinically relevant abnormalities identified by a detailed medical history, full
physical examination, including blood pressure and heart rate measurement, 12 lead ECG
and clinical laboratory tests.)

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, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)

NCT01462851
Pfizer
Completed
A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults

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A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults
A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05297909 25 mg
    Single oral (PO) dose, PF-05297909 25 mg
  • Drug: PF-05297909 100 mg
    Single oral (PO) dose, PF-05297909 100 mg
  • Drug: PF-05297909 250 mg
    Single oral (PO) dose, PF-05297909 250 mg
  • Drug: PF-05297909 525 mg
    Single oral (PO) dose, PF-05297909 525 mg
  • Drug: PF-05297909 525 mg
    Single oral (PO) dose, 525 mg
  • Experimental: Dose Escalation
    Ascending doses in healthy volunteers
    Interventions:
    • Drug: PF-05297909 25 mg
    • Drug: PF-05297909 100 mg
    • Drug: PF-05297909 250 mg
    • Drug: PF-05297909 525 mg
  • Experimental: Part 2: CSF PKPD
    Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment
    Intervention: Drug: PF-05297909 525 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01462851
B3941001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 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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