Clinical trial NCT01462851: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteer
safety
pharmacokinetic
pharmacodynamic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Plasma area under the curve last (AUClast) pharmacokinetic parameter
timeFrame: Day 1 to Day 3
measure: Plasma apparent clearance (CL/F) pharmacokinetic parameter
timeFrame: Day 0 to Day 3
measure: 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
timeFrame: Day 0 to Day 3
measure: Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
timeFrame: Day 1 to Day 3
measure: Plasma half-life (t1/2) pharmacokinetic parameter
timeFrame: Day 1 to Day 3
measure: Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
timeFrame: Day 1 to Day 3
measure: CSF concentration summary by time point for PF 05297909.
timeFrame: Day 1 to Day 3
measure: Change from baseline in CSF levels of Abeta40
timeFrame: Day 1 to Day 3
measure: Change from baseline in CSF levels of Abeta42
timeFrame: Day 1 to Day 3
measure: Change from baseline in CSF levels of AbetaX
timeFrame: Day 1 to Day 3
measure: Change from baseline in CSF levels of sAPPalpha
timeFrame: Day 1 to Day 3
measure: Change from baseline in CSF levels of sAPPbeta.
timeFrame: Day 1 to Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: