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

Phase 1CompletedNCT01918176

Pfizer26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Palbociclib aloneDRUG

Single dose of 125mg Palbociclib capsule will be administered to subjects orally and then PK samples will be collected at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.

Palbociclib + RabeprazoleDRUG

Two Rabeprazole 20mg tablets will be given to subjects orally once daily for 7 days. Then on the same day at least 4 hours after the last dose of Rabeprazole, single dose of 125mg Palbociclib capsule will be given to subjects orally then followed by PK samplings at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

South Miami, Florida, United States

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

Time frame: 0-120 hours

Maximum Observed Plasma Concentration (Cmax)

Time frame: 0-120 hours

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Time frame: 0-120 hours

Area Under the Curve from Time Zero to 72 hours

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours

Time frame: 0-72 hours

Apparent Oral Clearance (CL/F)

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Time frame: 0-120 hours

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 0-120 hours

Time For the Last Quantifiable Concentration (Tlast)

Time frame: 0-120 hours

Data from ClinicalTrials.gov

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