Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
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|ClinicalTrials.gov Identifier: NCT02131298|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : June 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Palbociclib Alone Drug: Palbociclib plus itraconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Open-Label, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole)
Drug: Palbociclib Alone
A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection
Other Name: Palbociclib, PD-0332991
Drug: Palbociclib plus itraconazole
Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
Other Name: Palbociclib (PD-0332991); Itraconazole (Sporanox)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0 to 168 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) [ Time Frame: 0 to 168 hours ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 to 168 hours ]Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 to 168 hours ]
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0 to 168 hours ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Apparent Oral Clearance (CL/F) [ Time Frame: 0 to 168 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) [ Time Frame: 0 to 168 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131298
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|