Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)

NCT04856293

Last updated date
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
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

1. Participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).

2. Male and female of non-childbearing potential participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

4. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in theICD and in this protocol.

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


1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease.


2. Any condition possibly affecting crizotinib absorption (eg, gastrectomy,
cholecystectomy, appendectomy).


3. History of HIV infection, chronic hepatitis B, or hepatitis C; positive testing for
HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or
hepatitis C antibody (HCVAb).


4. Positive COVID-19 test.


5. History of sensitivity to heparin or heparin induced thrombocytopenia.


6. Known history of hypersensitivity to crizotinib or any components of the formulations.


7. Other medical or psychiatric condition: recent or active suicidal ideation/behavior,
laboratory abnormality or conditions related to the COVID-19 pandemic that make the
participant inappropriate.


8. Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of crizotinib.


9. Previous administration with an investigational drug within 30 days or 5 half-lives
preceding the first dose of crizotinib (whichever is longer).


10. Positive urine drug test or cotinine test.


11. Supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5
minutes of supine rest. If BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), BP
should be repeated 2 more times.


12. Any clinically significant abnormality in 12-lead ECG, including QTcF >450 msec,
Computer-interpreted ECGs may be overread by a physician experienced in reading ECGs
before excluding participants.


13. AST or ALT level > (ULN); TBili level >ULN; participants with a history of Gilbert's
syndrome may have direct bilirubin <= ULN; eGFR <90 ml/min/1.73 m2 per CKD-EPI
equation.


14. Male participants who are unwilling or unable to comply with the contraception
requirement.


15. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.


16. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


17. Participants who currently smoke.


18. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.


19. Investigator site staff members or Pfizer employees directly involved in the conduct
of the study, site staff otherwise supervised by the investigator, and their
respective family members.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Healthy ParticipantsBioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
NCT04856293
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Healthy ParticipantsSTUDY OF PF-07321332 IN HEALTHY PARTICIPANTS
NCT04756531
  1. Brussels, Bruxelles-capitale, Région DE
  2. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
Official Title  ICMJE A PHASE 1, OPEN-LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE OF AN ENCAPSULATED MICROSPHERE FORMULATION (eMS) TO THE FORMULATED CAPSULE (FC) OF CRIZOTINIB IN HEALTHY ADULT PARTICIPANTS
Brief Summary Bioequivalence study to evaluate the pharmacokinetics of a new crizotinib encapsulated microsphere (eMS) formulation
Detailed Description

In order to overcome the poor taste/palatability associated with the original oral solution formulation of crizotinib for pediatric patients, an encapsulated microsphere (eMS) formulation with improved palatability compared with the oral solution and acceptable PK characteristics was developed.

The primary objective of this study is to establish the bioequivalence of the eMS formulation to the current commercial formulation, ie, formulated capsule (FC), in adult healthy participants to support the commercialization of this new formulation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: Crizotinib
    A single 250 mg crizotinib dose of the FC formulation
    Other Name: Treatment A
  • Drug: Crizotinib
    A single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation administered by sprinkling the contents into a dry glass vial
    Other Name: Treatment B
  • Drug: Crizotinib
    A single 250 mg crizotinib dose of the single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation (administered as intact capsules) . The intact capsules will be swallowed whole.
    Other Name: Treatment C
Study Arms  ICMJE
  • Experimental: Three Period Treatment Sequence
    Participants will receive a single 250 mg crizotinib dose of the formulated capsule(FC) formulation, a single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation administered by sprinkling the contents into a dry glass vial, and a single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation (administered as intact capsules)
    Interventions:
    • Drug: Crizotinib
    • Drug: Crizotinib
    • Drug: Crizotinib
  • Experimental: Two Period Treatment Sequence
    Participants will receive a single 250 mg crizotinib dose of the formulated capsule(FC) formulation, a single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation administered by sprinkling the contents into a dry glass vial
    Interventions:
    • Drug: Crizotinib
    • Drug: Crizotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2021)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 6, 2021
Estimated Primary Completion Date October 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  2. Male and female of non-childbearing potential participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
  3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  4. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in theICD and in this protocol.

Exclusion Criteria:

  1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
  2. Any condition possibly affecting crizotinib absorption (eg, gastrectomy, cholecystectomy, appendectomy).
  3. History of HIV infection, chronic hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb).
  4. Positive COVID-19 test.
  5. History of sensitivity to heparin or heparin induced thrombocytopenia.
  6. Known history of hypersensitivity to crizotinib or any components of the formulations.
  7. Other medical or psychiatric condition: recent or active suicidal ideation/behavior, laboratory abnormality or conditions related to the COVID-19 pandemic that make the participant inappropriate.
  8. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of crizotinib.
  9. Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of crizotinib (whichever is longer).
  10. Positive urine drug test or cotinine test.
  11. Supine BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), BP should be repeated 2 more times.
  12. Any clinically significant abnormality in 12-lead ECG, including QTcF >450 msec, Computer-interpreted ECGs may be overread by a physician experienced in reading ECGs before excluding participants.
  13. AST or ALT level > (ULN); TBili level >ULN; participants with a history of Gilbert's syndrome may have direct bilirubin <= ULN; eGFR <90 ml/min/1.73 m2 per CKD-EPI equation.
  14. Male participants who are unwilling or unable to comply with the contraception requirement.
  15. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  16. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  17. Participants who currently smoke.
  18. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  19. Investigator site staff members or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04856293
Other Study ID Numbers  ICMJE A8081074
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP