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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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 .

NCT01844323
Pfizer
Completed
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

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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
A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study In Healthy Volunteers To Estimate The Effect Of Active Pharmaceutical Ingredient Particle Size And Lubrication On The Bioavailability Of A Single 125 Mg Dose Of Palbociclib (PD-0332991) Administered Under Fasted Conditions
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Other: Palbociclib Formulation Reference
    Single 45 mg dose; Dosage form is capsule taken orally.
  • Other: Palbociclib Formulation Test
    Single 45 mg dose; Dosage form is capsule taken orally.
  • Active Comparator: Treatment A
    treatment A, reference, 20 micron palbociclib and lubrication level 1
    Intervention: Other: Palbociclib Formulation Reference
  • Active Comparator: Treatment B
    treatment B, test, 50 micron palbociclib and lubrication level 1
    Intervention: Other: Palbociclib Formulation Test
  • Active Comparator: Treatment C
    treatment C, test, 20 micron palbociclib and lubrication level 2
    Intervention: Other: Palbociclib Formulation Test
  • Active Comparator: Treatment D
    treatment D, test, 20 micron palbociclib and lubrication level 3
    Intervention: Other: Palbociclib Formulation Test
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2013
August 2013   (Final data collection date for primary outcome measure)

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 .
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01844323
A5481022
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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