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Clinical Trials/NCT01097876
NCT01097876
Completed
Phase 1

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

Pfizer1 site in 1 country24 target enrollmentApril 2010

Overview

Phase
Phase 1
Intervention
PF-04447943 25 mg
Conditions
Healthy
Sponsor
Pfizer
Enrollment
24
Locations
1
Primary Endpoint
Steady state PF 04447943 Cmax and AUCtau.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
July 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

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.

Arms & Interventions

Active PF-04447943

Intervention: PF-04447943 25 mg

Placebo PF-04447943

Intervention: Placebo PF

Outcomes

Primary Outcomes

Steady state PF 04447943 Cmax and AUCtau.

Time Frame: up through day 44

Steady state Donepezil Cmax and AUCtau.

Time Frame: up through day 44

Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.

Time Frame: up through day 44

Secondary Outcomes

  • There are no Secondary Endpoints(There are no Secondary Endpoints)

Study Sites (1)

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