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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

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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-05297909 25 mg
Drug: PF-05297909 100 mg
Drug: PF-05297909 250 mg
Drug: PF-05297909 525 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 51
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Part 2: CSF PKPD
Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment
Drug: PF-05297909 525 mg
Single oral (PO) dose, 525 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462851

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01462851     History of Changes
Other Study ID Numbers: B3941001
Study First Received: September 8, 2011
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
healthy volunteer
safety
pharmacokinetic
pharmacodynamic

ClinicalTrials.gov processed this record on November 20, 2014