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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05297909 25 mg; Drug: PF-05297909 100 mg; Drug: PF-05297909 250 mg; Drug: PF-05297909 525 mg

• Registration Number: NCT01462851
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	PF-05297909 25 mg	Ascending doses in healthy volunteers
Dose Escalation	PF-05297909 100 mg	Ascending doses in healthy volunteers
Dose Escalation	PF-05297909 250 mg	Ascending doses in healthy volunteers
Dose Escalation	PF-05297909 525 mg	Ascending doses in healthy volunteers
Part 2: CSF PKPD	PF-05297909 525 mg	Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States