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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01462851
First received: September 8, 2011
Last updated: March 12, 2012
Last verified: March 2012

September 8, 2011
March 12, 2012
September 2011
February 2012   (final data collection date for primary outcome measure)
  • Plasma area under the curve last (AUClast) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma apparent clearance (CL/F) pharmacokinetic parameter [ Time Frame: Day 0 to Day 3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma half-life (t1/2) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • CSF concentration summary by time point for PF 05297909. [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Change from baseline in CSF levels of Abeta40 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Change from baseline in CSF levels of Abeta42 [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Change from baseline in CSF levels of AbetaX [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Change from baseline in CSF levels of sAPPalpha [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
  • Change from baseline in CSF levels of sAPPbeta. [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01462851 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01462851
B3941001
No
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