Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01918176
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fixed sequence crossover Palbociclib + Rabeprazole All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole. Fixed sequence crossover Palbociclib alone All the subjects will undergo the treatment of Palbociclib alone first and then treatment of Palbociclib and Rabeprazole.
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] 0-120 hours 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).
Maximum Observed Plasma Concentration (Cmax) 0-120 hours
- Secondary Outcome Measures
Name Time Method Time For the Last Quantifiable Concentration (Tlast) 0-120 hours Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] 0-120 hours AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Area Under the Curve from Time Zero to 72 hours 0-72 hours AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax) 0-120 hours Apparent Oral Clearance (CL/F) 0-120 hours 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.
Apparent Volume of Distribution (Vz/F) 0-120 hours Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Plasma Decay Half-Life (t1/2) 0-120 hours Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸South Miami, Florida, United States