A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer Subjects

A Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Healthy Volunteers When Combined With Donepezil

The purpose of this study is to evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-04447943 25 mg; Drug: Placebo PF

Detailed Description

Evaluate the safety and tolerability of PF-04447943, before and after multiple doses of donepezil in healthy volunteers. Evaluate the plasma drug levels of both PF-04447943 and donepezil.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female of non-childbearing potential subjects between the ages of 21 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 pulse 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 females; females of childbearing potential.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active PF-04447943	Drug: PF-04447943 25 mg; 25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3)
Placebo Comparator: Placebo PF-04447943	Drug: Placebo PF; Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Steady state PF 04447943 Cmax and AUCtau.	up through day 44
Steady state Donepezil Cmax and AUCtau.	up through day 44
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.	up through day 44

Secondary Outcome Measures

Outcome Measure	Time Frame
There are no Secondary Endpoints	There are no Secondary Endpoints

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 4, 2010
• Last Update Submitted That Met QC Criteria: August 3, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: safety; healthy volunteer; pharmacokinetic
• Other Study ID Numbers: B0401012