Relative Bioavailability For Palbociclib Formulations
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|ClinicalTrials.gov Identifier: NCT02083640|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Palbociclib Formulation Reference Drug: Palbociclib Formulation Test||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Open-Label, 6 Sequence, 3 Period, Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Relative Bioavailability Of 3 Palbociclib Formulations|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
|Treatment A (Reference)||
Drug: Palbociclib Formulation Reference
125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.
|Treatment B (Test)||
Drug: Palbociclib Formulation Test
125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1
|Treatment C (Test)||
Drug: Palbociclib Formulation Test
125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 6 days ]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: 6 days ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 6 days ]Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Apparent Oral Clearance (CL/F) [ Time Frame: 6 days ]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 to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 Days ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: 6 days ]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) [ Time Frame: 6 days ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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): NCT02083640
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|