Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01193062
First received: August 25, 2010
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274 single dose administration in healthy volunteers will also be assessed as part of the objectives.


Condition Intervention Phase
Healthy
Drug: PF-04995274
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1 Investigator And Subject-Blind Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Doses Of PF-04995274 On Sapp-Alpha Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Endpoints (AE's, Vital signs, ECG, Clinical safety laboratory endpoints, Clinical examinations) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
  • Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in plasma, as the data permit [ Time Frame: upto 5 days post dose ] [ Designated as safety issue: No ]
  • Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274 and PF-05082547 in cerebrospinal fluid, as the data permit [ Time Frame: upto 8 hrs post dose ] [ Designated as safety issue: No ]
  • Cmax, Tmax, AUClast, AUCinf, and t1/2 of s-APP alpha and Abeta fragments in cerebrospinal fluid, as the data permit [ Time Frame: 8 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK/PD model [ Time Frame: 8 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
Drug: PF-04995274
Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
Experimental: Cohort 2
Subjects will be receive single oral doses of PF-04995274 not exceeding 15mg or a placebo
Drug: PF-04995274
Doses for cohort 2 will be decided based on an Interim analysis of data from cohort 1. The highest dose to be used in Cohort 2 not to exceed 15mg

Detailed Description:

The purpose of the study is to evaluate the effect of PF-04995274 on CSF levels of s-APP and Abeta fragments following single oral dose in healthy volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For all cohorts, healthy male and/or female subjects of nonchildbearing 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).
  • Pregnant or nursing women; women of childbearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193062

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01193062     History of Changes
Other Study ID Numbers: B1661004
Study First Received: August 25, 2010
Last Updated: January 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
healthy volunteers
pharmacokinetics-pharmacodynamics
cerebrospinal fluid
serial sampling

ClinicalTrials.gov processed this record on July 20, 2014