Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Palbociclib alone; Drug: Palbociclib + Rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01918176

A5481018

Details and patient eligibility

About

Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of Rabeprazole might affect the absorption process of Palbociclib.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.

Exclusion criteria

• A positive urine drug screen, urine cotinine test or alcohol breath test.
• Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.

Trial design

26 participants in 1 patient group

Fixed sequence crossover

Experimental group

Description:

All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole.

Treatment:

Drug: Palbociclib + Rabeprazole

Drug: Palbociclib alone