Food Effect Study Of AG-013736 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AG-013736

Study type: Interventional

Funder types: Industry

Identifiers

NCT00918632

A4061053

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 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 Electrocardiogram (ECG) and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion criteria

• Evidence of history of clinically significant blood, kidney, endocrine, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
• Active smokers or users of other tobacco products as well as users of certain drugs.
• Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone (FSH) test results at Screening.

Trial design

30 participants in 6 patient groups

Sequence 1 (ABC)

Other group

Description:

The following treatments will be administered in the following order A -\> B-\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Sequence 2 (ACB)

Other group

Description:

The following treatments will be administered in the following order A -\> C -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Sequence 3 (BCA)

Other group

Description:

The following treatments will be administered in the following order B -\> C -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Sequence 4 (BAC)

Other group

Description:

The following treatments will be administered in the following order B -\> A -\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Sequence 5 (CAB)

Other group

Description:

The following treatments will be administered in the following order C -\> A -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Sequence 6 (CBA)

Other group

Description:

The following treatments will be administered in the following order C -\> B -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736