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Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants

Last updated on December 3, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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

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

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Participants enrolling as Japanese must have 4 biological Japanese grandparents who
were born in Japan.

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

- 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
investigational product.

- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of investigational
product used in this study (whichever is longer).

- Screening supine blood pressure (BP) ?140 mm Hg (systolic) or ?90 mm Hg (diastolic),
following at least 5 minutes of supine rest.

- Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block
[LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval
changes suggestive of myocardial ischemia, second- or third-degree atrioventricular
[AV] block, or serious bradyarrhythmias or tachyarrhythmias).

- Participants with any of the following abnormalities in clinical laboratory tests at
screening: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level
?1.25× upper limit of normal (ULN); Total bilirubin level ?1.5× ULN; participants with
a history of Gilbert's syndrome may have direct bilirubin measured and would be
eligible for this study provided the direct bilirubin level is ? ULN.

NCT04044053
Pfizer
Completed
Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants

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Descriptive Information
Brief Title  ICMJE Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants
Official Title  ICMJE A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 4-PERIOD, 4-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY OF A MODIFIED-RELEASE FORMULATION OF PF-06865571 RELATIVE TO AN IMMEDIATE-RELEASE FORMULATION UNDER FED CONDITIONS, AND TO EVALUATE THE EFFECT OF FASTING ON THE PHARMACOKINETICS OF THE MODIFIED-RELEASE FORMULATION, IN HEALTHY WESTERN AND JAPANESE PARTICIPANTS
Brief SummaryThis study is an open-label, randomized, single-dose, 4-period, 4-sequence, crossover study in a single cohort of approximately 12 healthy adult participants. The purpose of this study is to evaluate the relative bioavailability of a newly developed modified release (MR) tablet formulation of PF-06865571 relative to an immediate release (IR) tablet formulation of PF-06865571 under fed conditions. In addition, this study will also assess the relative bioavailability of the MR formulation under fasted conditions relative to fed conditions, in healthy adult participants. Study results will be used to determine if the new MR formulation may be suitable for use in future clinical studies with PF-06865571. Healthy adult Japanese participants will also be enrolled in this study to support inclusion of Japanese participants in future clinical studies.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: PF-06865571 400 mg Immediate Release (IR) in Fed State
    400 mg IR dose in fed state
  • Drug: PF-06865571 50 mg Modified Release (MR) in Fed State
    50 mg MR in fed state
  • Drug: PF-06865571 400 mg MR in Fed State
    400 mg MR in fed state
  • Drug: PF-06865571 400 mg MR in Fasted State
    400 mg MR in fasted state
Study Arms  ICMJE
  • Experimental: Relative Bioavailability
    Each participant will receive 400 mg IR, 400 mg MR, and 50 mg MR in the fed state, and 400 mg MR in the fasted state
    Interventions:
    • Drug: PF-06865571 400 mg Immediate Release (IR) in Fed State
    • Drug: PF-06865571 50 mg Modified Release (MR) in Fed State
    • Drug: PF-06865571 400 mg MR in Fed State
    • Drug: PF-06865571 400 mg MR in Fasted State
  • Experimental: Fasted State
    Comparison of 400 mg MR in fed and fasted states
    Interventions:
    • Drug: PF-06865571 400 mg MR in Fed State
    • Drug: PF-06865571 400 mg MR in Fasted State
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion DateOctober 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female participants of non-childbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • 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 investigational product.
  • Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
  • Screening supine blood pressure (BP) ?140 mm Hg (systolic) or ?90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
  • Participants with any of the following abnormalities in clinical laboratory tests at screening: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ?1.25× upper limit of normal (ULN); Total bilirubin level ?1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ? ULN.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04044053
Other Study ID Numbers  ICMJE C2541012
2019-001426-96 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:Yes
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

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

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

BY PHONE

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1-800-718-1021

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