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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-05297909 25 mg; Drug: PF-05297909 100 mg; Drug: PF-05297909 250 mg; Drug: PF-05297909 525 mg; Drug: PF-05297909 525 mg

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose Escalation; Ascending doses in healthy volunteers	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: Part 2: CSF PKPD; Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment	Drug: PF-05297909 525 mg; Single oral (PO) dose, PF-05297909 525 mg; Drug: PF-05297909 525 mg; Single oral (PO) dose, 525 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma area under the curve last (AUClast) pharmacokinetic parameter	Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter	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	Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter	Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter	Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter	Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.	Day 1 to Day 3
Change from baseline in CSF levels of Abeta40	Day 1 to Day 3
Change from baseline in CSF levels of Abeta42	Day 1 to Day 3
Change from baseline in CSF levels of AbetaX	Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha	Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.	Day 1 to Day 3

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (ESTIMATE): October 31, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2012
• Last Update Submitted That Met QC Criteria: March 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: safety; healthy volunteer; pharmacokinetic; pharmacodynamic
• Other Study ID Numbers: B3941001