NCT01462851

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2011

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

September 8, 2011

Last Update Submit

March 12, 2012

Conditions

Healthy

Keywords

healthy volunteersafetypharmacokineticpharmacodynamic

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Ascending doses in healthy volunteers

Drug: PF-05297909 25 mgDrug: PF-05297909 100 mgDrug: PF-05297909 250 mgDrug: PF-05297909 525 mg

Part 2: CSF PKPD

EXPERIMENTAL

Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment

Drug: PF-05297909 525 mg

Interventions

PF-05297909 25 mgDRUG

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

Dose Escalation
PF-05297909 100 mgDRUG

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

Dose Escalation
PF-05297909 250 mgDRUG

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

Dose Escalation
PF-05297909 525 mgDRUG

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

Dose Escalation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

October 31, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

US(2)