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Trial record 1 of 1 for:    NCT01462851
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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

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ClinicalTrials.gov Identifier: NCT01462851
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2011
First Posted Date  ICMJE October 31, 2011
Last Update Posted Date March 13, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
  • Plasma area under the curve last (AUClast) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ]
  • Plasma apparent clearance (CL/F) pharmacokinetic parameter [ Time Frame: Day 0 to Day 3 ]
  • Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model [ Time Frame: Day 0 to Day 3 ]
  • Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ]
  • Plasma half-life (t1/2) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ]
  • Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ]
  • CSF concentration summary by time point for PF 05297909. [ Time Frame: Day 1 to Day 3 ]
  • Change from baseline in CSF levels of Abeta40 [ Time Frame: Day 1 to Day 3 ]
  • Change from baseline in CSF levels of Abeta42 [ Time Frame: Day 1 to Day 3 ]
  • Change from baseline in CSF levels of AbetaX [ Time Frame: Day 1 to Day 3 ]
  • Change from baseline in CSF levels of sAPPalpha [ Time Frame: Day 1 to Day 3 ]
  • Change from baseline in CSF levels of sAPPbeta. [ Time Frame: Day 1 to Day 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2012)
51
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2011)
56
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01462851
Other Study ID Numbers  ICMJE B3941001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP