A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult Participants

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04447943

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886093

B0401006

Details and patient eligibility

About

The purpose of the study is to compare the plasma drug levels of PF-04447943 when taken as a 35 mg tablet after a high fat meal compared to when taken after fasting. Healthy adult volunteers will receive a single dose of the drug once when fasted and again when fed. The safety and tolerability of the drug will be monitored.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects, not of child bearing potential.
• Age 18-55 inclusive
• Total body weight >50 kg.

Exclusion criteria

• Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
• History of orthostatic blood pressure changes or orthostatic symptoms
• Greater than 7 drinks of alcohol per week for women and greater than 14 drinks per week for men
• Smoking more than 5 cigarettes per day

Trial design

10 participants in 2 patient groups

Sequence 1

Experimental group

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Sequence 2

Experimental group

Treatment:

Drug: PF-04447943

Drug: PF-04447943