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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01462851

Enrollment

Registered

2011-10-31

Start date

2011-09-30

Completion date

2012-02-29

Last updated

2012-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy volunteer, safety, pharmacokinetic, pharmacodynamic

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.

Interventions

DRUGPF-05297909 25 mg

Single oral (PO) dose, PF-05297909 25 mg

DRUGPF-05297909 100 mg

Single oral (PO) dose, PF-05297909 100 mg

DRUGPF-05297909 250 mg

Single oral (PO) dose, PF-05297909 250 mg

DRUGPF-05297909 525 mg

Single oral (PO) dose, PF-05297909 525 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026