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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Study Overview
Brief Summary
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg oral doses under fed conditions in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male subjects and/or female subjects with no physical possibility of getting pregnant.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication.
- •Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .
Arms & Interventions
Treatment A (Reference)
Intervention: Palbociclib Formulation Reference (Drug)
Treatment C (Test)
Intervention: Palbociclib Formulation Test (Drug)
Treatment B (Test)
Intervention: Palbociclib Formulation Test (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Apparent Oral Clearance (CL/F)(6 days)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(6 days)
- Apparent Volume of Distribution (Vz/F)(6 days)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(2 Days)
- Plasma Decay Half-Life (t1/2)(6 days)