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
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.
Investigators
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)