A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Palbociclib Formulation Reference; Other: Palbociclib Formulation Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844323

A5481022

Details and patient eligibility

About

The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Treatment A

Active Comparator group

Description:

treatment A, reference, 20 micron palbociclib and lubrication level 1

Treatment:

Other: Palbociclib Formulation Reference

Treatment B

Active Comparator group

Description:

treatment B, test, 50 micron palbociclib and lubrication level 1

Treatment:

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test

Treatment C

Active Comparator group

Description:

treatment C, test, 20 micron palbociclib and lubrication level 2

Treatment:

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test

Treatment D

Active Comparator group

Description:

treatment D, test, 20 micron palbociclib and lubrication level 3

Treatment:

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test

Other: Palbociclib Formulation Test