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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04447943 25 mg; Drug: Placebo PF

• Registration Number: NCT01097876
• Lead Sponsor: Pfizer

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-31
• Study Start: 2010-04
• Study First Posted: 2010-04-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-03
• Last Update Posted: 2010-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active PF-04447943	PF-04447943 25 mg	-
Placebo PF-04447943	Placebo PF	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
There are no Secondary Endpoints	There are no Secondary Endpoints

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore