A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations

NCT04338711

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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 and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

- Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

1. . Achieved postmenopausal status, defined as: cessation of regular menses for at lease 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;

2. . have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. . have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight ˃50 kg (110 lbs) for males and ˃45 kg (99 lbs) for females

- No evidence of active or latent or inadequately treated infection with Mycobaceterium tuberculosis (TB)

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


- Evidence or history of clinical significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
season allergies at the time of dosing.


- Clinically significant infections within the past 3 months (for example, those
requiring hospitalization or parenteral antibiotics, or as judged by the
investigator), evidence of any infection within the past 7 days, history of
disseminated herpes simplex infection or recurrent (˃1 episode) herpes zoster or
disseminated herpes zoster.


- Absolute lymphocyte count at Screening or Baseline (Day -1 of Period 1) less than the
lower limit of the reference range for the local laboratory (lymphocyte count ˂0.8*
10˄3).


- Evidence of hematopoietic disorder or hemoglobin ˂12.5 g/dL for females and ˂13 g/dL
for males at Screening or Baseline ((Day -1 of Period 1).


- Evidence or history of cyclic neutropenia.


- Personal or family history of hereditary immunodeficiency (eg, severe combined
immunodeficiency disorder [SCID], Wiskott-Aldrich syndrome, X-linked
agammaglobulinemia).


- Vaccination with live or attenuated vaccines within 6 weeks of dosing, or is to be
vaccinated with these vaccines at any time during study treatment or within 6 weeks
following discontinuation of dosing.


- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,
etc.).


- History of, or current positive results for any of the following serological tests:
human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for
HIV, hepatits B surface antigen (HepBsAg), Hepatitis B surface antibody (HBsAb),
hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).


- Malignancy or a history of malignancy, with the exception of adequately treated or
excised non-metastatic basal cell or squamous cell cancer of the skin or cervical
carcinoma in situ.


- Positive urine drug test.


- History of regular alcohol consumption.


- Use of tobacco-or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.


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


- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval ˃450 msec or
a QRS interval ˃120 msec.


- Nursing females or females of childbering potential. Male subjects who are unwilling
or unable to use a condom plus a highly effective method of contraception as outline
in this protocol for the duration of the study and for at least 28 days after the last
dose of investigational product.


- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of investigational product.
Herbal supplements and hormone replacement therapy must be discontinued at least 28
days prior to the first dose of investigational product.


- Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg,
phenytoin, carbamazepine, rifampin) within 14 days or 5 half-lives (whichever is
longer) prior to dosing.


- Consumption of grapefruit or grapefruit-related citrus fruits (eg, Seville oranges,
pomelos) or juices within 7 days prior to dosing.


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


- History of sensitivity to heparin or heparing-induced thrombocytopenia.


- History of hypersensitivity to tofacitinib or any of the components of the
formulation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study In Adult Healthy Volunteers To Asses Once Daily (QD) Dosing With The Selected Age-Appropriate Modified Release (MR) Formulations
Official Title  ICMJE A PHASE 1, RANDOMIZED, OPEN LABEL, PARTIAL CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF THREE AGE-APPROPRIATE MODIFIED RELEASE FORMULATIONS AND THE IMMEDIATE RELEASE SOLUTION OF TOFACITINIB IN HEALTHY ADULT VOLUNTEERS
Brief Summary The purpose of this study is to evaluate the pharmacokinetic (PK) and safety of an age-appropriate tofacitinib Modified Release (MR) formulation with varying level of enteric coating. The effect of food on the PK of age-appropriate tofacitinib MR formulation with the lowest and higher levels of enteric coating will also be assessed.
Detailed Description Not 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: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: tofacitinib modified release (MR)

Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state.

Treatment F: a 10 mg oral dose of tofacitinib IR solution

Study Arms  ICMJE
  • Experimental: Treatment A
    Single oral 10 mg dose of tofacitinib MR E1 administered in the fasted state.
    Intervention: Drug: tofacitinib modified release (MR)
  • Experimental: Treatment B
    Single oral 10 mg dose of tofacitinib MR E2 administered in the fasted state.
    Intervention: Drug: tofacitinib modified release (MR)
  • Experimental: Treatment C
    Single oral 10 mg dose of tofacitinib MR E3 administered in the fasted state.
    Intervention: Drug: tofacitinib modified release (MR)
  • Experimental: Treatment D
    Single oral 10 mg dose of tofacitinib MR E1 administered in the fed state.
    Intervention: Drug: tofacitinib modified release (MR)
  • Experimental: Treatment E
    Single oral 10 mg dose of tofacitinib MR E3 administered in the fed state.
    Intervention: Drug: tofacitinib modified release (MR)
  • Active Comparator: Treatment F
    Single oral 10 mg dose of tofacitinib IR Solution (10 mL of the 1 mg/mL solution) administered in the fasted state.
    Intervention: Drug: tofacitinib modified release (MR)
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2020
Estimated Primary Completion Date October 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
  • Female subjects of non-childbearing potential must meet at least 1 of the following criteria:

    1. . Achieved postmenopausal status, defined as: cessation of regular menses for at lease 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
    2. . have undergone a documented hysterectomy and/or bilateral oophorectomy;
    3. . have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight ?50 kg (110 lbs) for males and ?45 kg (99 lbs) for females
  • No evidence of active or latent or inadequately treated infection with Mycobaceterium tuberculosis (TB)

Exclusion Criteria:

  • Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, season allergies at the time of dosing.
  • Clinically significant infections within the past 3 months (for example, those requiring hospitalization or parenteral antibiotics, or as judged by the investigator), evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (?1 episode) herpes zoster or disseminated herpes zoster.
  • Absolute lymphocyte count at Screening or Baseline (Day -1 of Period 1) less than the lower limit of the reference range for the local laboratory (lymphocyte count ?0.8* 10?3).
  • Evidence of hematopoietic disorder or hemoglobin ?12.5 g/dL for females and ?13 g/dL for males at Screening or Baseline ((Day -1 of Period 1).
  • Evidence or history of cyclic neutropenia.
  • Personal or family history of hereditary immunodeficiency (eg, severe combined immunodeficiency disorder [SCID], Wiskott-Aldrich syndrome, X-linked agammaglobulinemia).
  • Vaccination with live or attenuated vaccines within 6 weeks of dosing, or is to be vaccinated with these vaccines at any time during study treatment or within 6 weeks following discontinuation of dosing.
  • Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
  • History of, or current positive results for any of the following serological tests: human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatits B surface antigen (HepBsAg), Hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  • Malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • Positive urine drug test.
  • History of regular alcohol consumption.
  • Use of tobacco-or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of the investigational product (whichever is longer).
  • Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval ?450 msec or a QRS interval ?120 msec.
  • Nursing females or females of childbering potential. Male subjects who are unwilling or unable to use a condom plus a highly effective method of contraception as outline in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of investigational product.
  • Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, phenytoin, carbamazepine, rifampin) within 14 days or 5 half-lives (whichever is longer) prior to dosing.
  • Consumption of grapefruit or grapefruit-related citrus fruits (eg, Seville oranges, pomelos) or juices within 7 days prior to dosing.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparing-induced thrombocytopenia.
  • History of hypersensitivity to tofacitinib or any of the components of the formulation.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04338711
Other Study ID Numbers  ICMJE A3921262
Has Data Monitoring Committee Not Provided
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 2020

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