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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01462851
• Collaborator: (none)
• Enrollment: 51
• Locations: 2
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 25.5
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-05297909 25 mg; Drug: PF-05297909 100 mg; Drug: PF-05297909 250 mg; Drug: PF-05297909 525 mg; Drug: PF-05297909 525 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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 Start Date: Sep 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Ascending doses in healthy volunteers	Drug: PF-05297909 25 mg; Single oral (PO) dose, PF-05297909 25 mg; Drug: PF-05297909 100 mg; Single oral (PO) dose, PF-05297909 100 mg; Drug: PF-05297909 250 mg; Single oral (PO) dose, PF-05297909 250 mg; Drug: PF-05297909 525 mg; Single oral (PO) dose, PF-05297909 525 mg
Experimental: Part 2: CSF PKPD Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment	Drug: PF-05297909 525 mg; Single oral (PO) dose, 525 mg

Outcome Measures

Primary Outcome Measures

1. Plasma area under the curve last (AUClast) pharmacokinetic parameter [Day 1 to Day 3]

2. Plasma apparent clearance (CL/F) pharmacokinetic parameter [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 [Day 0 to Day 3]

4. Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter [Day 1 to Day 3]

5. Plasma half-life (t1/2) pharmacokinetic parameter [Day 1 to Day 3]

6. Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter [Day 1 to Day 3]

7. CSF concentration summary by time point for PF 05297909. [Day 1 to Day 3]

8. Change from baseline in CSF levels of Abeta40 [Day 1 to Day 3]

9. Change from baseline in CSF levels of Abeta42 [Day 1 to Day 3]

10. Change from baseline in CSF levels of AbetaX [Day 1 to Day 3]

11. Change from baseline in CSF levels of sAPPalpha [Day 1 to Day 3]

12. Change from baseline in CSF levels of sAPPbeta. [Day 1 to Day 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Glendale	California	United States	91206
2	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01462851
• Other Study ID Numbers: B3941001
• First Posted: Oct 31, 2011
• Last Update Posted: Mar 13, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Pfizer: healthy volunteer; safety; pharmacokinetic; pharmacodynamic

Study Results

No Results Posted as of Mar 13, 2012