Food Effect Study Of AG-013736 In Healthy Volunteers

Summary

The study is designed to evaluate the effect of food on typical blood levels obtained after oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a high-fat, high-calorie meal.

Conditions

• Healthy Volunteers

Interventions

DRUG

AG-013736

A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -\> B -\> C. Each of these treatments will be separated by a 7 day washout period.

DRUG

AG-013736

A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -\> C -\> B. Each of these treatments will be separated by a 7 day washout period.

DRUG

AG-013736

A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -\> C -\> A. Each of these treatments will be separated by a 7 day washout period.

DRUG

AG-013736

A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -\> A -\> C. Each of these treatments will be separated by a 7 day washout period.

DRUG

AG-013736

A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -\> A -\> B. Each of these treatments will be separated by a 7 day washout period.

DRUG

AG-013736

A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -\> B -\> A. Each of these treatments will be separated by a 7 day washout period.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2009-07-31

Completion

2009-07-31

Countries

• Belgium

Study Locations