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NCT Number: 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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PF-05297909 25 mg

Drug

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

PF-05297909 100 mg

Drug

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

PF-05297909 250 mg

Drug

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

PF-05297909 525 mg

Drug

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

Primary outcomes

  1. Plasma area under the curve last (AUClast) pharmacokinetic parameter

    Time frame: Day 1 to Day 3

  2. Plasma apparent clearance (CL/F) pharmacokinetic parameter

    Time frame: Day 0 to Day 3

  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

    Time frame: Day 0 to Day 3

  4. Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter

    Time frame: Day 1 to Day 3

  5. Plasma half-life (t1/2) pharmacokinetic parameter

    Time frame: Day 1 to Day 3

  6. Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter

    Time frame: Day 1 to Day 3

  7. CSF concentration summary by time point for PF 05297909.

    Time frame: Day 1 to Day 3

  8. Change from baseline in CSF levels of Abeta40

    Time frame: Day 1 to Day 3

  9. Change from baseline in CSF levels of Abeta42

    Time frame: Day 1 to Day 3

  10. Change from baseline in CSF levels of AbetaX

    Time frame: Day 1 to Day 3

  11. Change from baseline in CSF levels of sAPPalpha

    Time frame: Day 1 to Day 3

  12. Change from baseline in CSF levels of sAPPbeta.

    Time frame: Day 1 to Day 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2011
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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