Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: dacomitinib fed; Drug: dacomitinib fasted; Drug: dacomitinib+antacid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702506

A7471015

Details and patient eligibility

About

Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
• 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.

Exclusion criteria

• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Fasted

Experimental group

Description:

Dacomitinib administered under fasted conditions

Treatment:

Drug: dacomitinib fasted

Fed

Experimental group

Description:

Dacomitinib administered under fed conditions

Treatment:

Drug: dacomitinib fed

Antacid

Experimental group

Description:

Dacomitinib administered under antacid treatment

Treatment:

Drug: dacomitinib+antacid