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Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

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ClinicalTrials.gov Identifier: NCT04065633
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE July 18, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Plasma PF-04965842 PK parameters [ Time Frame: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose ]
    AUCinf
  • Plasma PF-04965842 PK parameters [ Time Frame: hour 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours post-dose ]
    Cmax
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • number of subjects with treatment-emergent adverse event [ Time Frame: baseline until Period 4 study day 35 ]
  • number of subjects with significant change from baseline in Supine Blood pressure, pulse rate and oral temperature [ Time Frame: baseline until Period 4 study day 3 ]
    The actual and the change from baseline values will be summarized by treatment. These data will be listed and out of range values will be summarized
  • number of subjects with significant Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR [ Time Frame: baseline until Period 4 study day 3 ]
    Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR interval, and QRS complex will be summarized by treatment and time. The number (%) of participants with maximum postdose QTc values and maximum increases from baseline in the following categories will be tabulated by treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Official Title  ICMJE A PHASE 1, OPEN LABEL, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF A COMMERCIAL TABLET FORMULATION OF PF-04965842 RELATIVE TO THE PHASE III TABLET FORMULATION UNDER FASTING CONDITIONS AND THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF THE COMMERCIAL TABLET FORMULATION IN HEALTHY PARTICIPANTS
Brief Summary

Part A

  • To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions
  • To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions
  • To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation

Part B

• To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions

Parts A & B

  • To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize [break down] certain medications)

    o Genotyping is the collection of a small sample of blood that contains your genes

  • To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants
  • To measure the amount of study drug in the blood after single doses of the different formulations
  • To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing
Detailed Description

The purpose of this study in healthy participants is to estimate the bioavailability (BA) of the commercial formulation of PF-04965842 and a variant formulation with slower dissolution relative to the Phase 3 formulation, to demonstrate the bioequivalence (BE) of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the BA of the commercial formulation. This study consists of 2 parts: Part A is to estimate the relative BA (rBA) of single 200 mg doses of the commercial tablet formulation of PF-04965842 and a variant formulation of slower dissolution rate compared to the Phase 3 tablet formulation. The effect of food on the BA of the commercial tablet formulation will also be evaluated. Part B is to establish BE between the Phase 3 and commercial formulations. The study will follow a staged approach as the sample size for BE cannot be determined with currently available information.

Therefore, it is proposed to assess the maximum observed concentration (Cmax) and area under the curve (AUC) ratios between the Phase 3 and commercial formulations as well as the within-participant variability of Cmax and AUC values determined in Part A. Based on the results from Part A, the sample size of Part B will be determined and the decision to proceed to Part B will be made.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a Phase 1 randomized, open label, single-dose, crossover study in healthy participants to estimate the rBA of the commercial formulation of PF-04965842 (Test formulation 1) and the variant formulation with slower dissolution (Test formulation 2) compared to the Phase 3 formulation (Reference formulation), to demonstrate the BE of the commercial formulation relative to the Phase 3 formulation, and to estimate the effect of food on the rBA of the commercial formulation after a single 200 mg oral dose.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: P3-Fast
    200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions
  • Drug: Comm-Fast
    200 mg PF-04965842 commercial tablet formulation under fasted conditions
  • Drug: Vari-Fast
    200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions
  • Drug: Comm-Fed
    200 mg PF-04965842 commercial tablet formulation under fed conditions
Study Arms  ICMJE
  • Experimental: Part A sequence 1
    Interventions:
    • Drug: P3-Fast
    • Drug: Comm-Fast
    • Drug: Vari-Fast
    • Drug: Comm-Fed
  • Experimental: Part A sequence 2
    Interventions:
    • Drug: P3-Fast
    • Drug: Comm-Fast
    • Drug: Vari-Fast
    • Drug: Comm-Fed
  • Experimental: Part B sequence 1
    Interventions:
    • Drug: P3-Fast
    • Drug: Comm-Fast
  • Experimental: Part B sequence 2
    Interventions:
    • Drug: P3-Fast
    • Drug: Comm-Fast
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: November 20, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
64
Actual Study Completion Date  ICMJE December 14, 2019
Actual Primary Completion Date December 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).

    • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
    • Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) .History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
    • History of chronic infections, history of recurrent infections, history of latent infections, .History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
    • history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065633
Other Study ID Numbers  ICMJE B7451032
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/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Sylvester Pawlak, APRN Pfizer
PRS Account Pfizer
Verification Date January 2020

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