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

NCT01844323 | Completed Phase 1

• 1 other identifier: A5481022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time

  AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  7 days

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  7 days

• Maximum Observed Plasma Concentration (Cmax)

  2 days

Secondary Outcomes (6)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  7 days

• Area under the Concentration-Time Curve (AUC) from 0 to 72

  3 days

• Apparent Oral Clearance (CL/F)

  7 days

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  2 days

• Apparent Volume of Distribution (Vz/F)

  7 days

Study Arms (4)

Treatment A

ACTIVE COMPARATOR

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

Other: Palbociclib Formulation Reference

Treatment B

ACTIVE COMPARATOR

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

Other: Palbociclib Formulation Test

Treatment C

ACTIVE COMPARATOR

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

Other: Palbociclib Formulation Test

Treatment D

ACTIVE COMPARATOR

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

Other: Palbociclib Formulation Test

Interventions

Palbociclib Formulation Reference OTHER

Single 45 mg dose; Dosage form is capsule taken orally.

Treatment A

Palbociclib Formulation Test OTHER

Single 45 mg dose; Dosage form is capsule taken orally.

Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 1, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

US (1)