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PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-254-6398
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 nonchildbearing potential must meet at least 1 of the following
criteria:

1. Achieved postmenopausal status, defined as: cessation of regular menses for at
least 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 per m2; and a total body weight above 50 kg
(110 lbs) for males and above 45 kg (99 lbs) for females.

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

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

- Clinically significant infections within the past 3 months, 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 less than the lower limit of the
reference range for the local laboratory

- Evidence or history of cyclic neutropenia.

- Personal or family history of hereditary immunodeficiency

- Vaccination with live or attenuated vaccines within the 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;

- 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 investigational product
(whichever is longer).

- Nursing females or females of childbearing potential. Male subjects who are unwilling
or unable to use a condom plus a highly effective method of contraception as outlined
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 or inducers 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 heparin-induced thrombocytopenia.

NCT03112148
Pfizer
Completed
PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

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PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations
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
This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution

For the the relative bioavailability (BA) assessment , the investigational product(s) are:

Test: 10 mg dose of age-appropriate MR formulations (MR-fast, MR-moderate, MR-slow). Each formulation contains 0.025 mg of tofacitinib/mg of microsphere. Reference: 10 mg dose of tofacitinib IR solution (1 mg of tofacitinib/mL).

For the the food effect assessment, the investigational product(s) are:

Test: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) c-oadministered with high-fat FDA breakfast. Reference: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) administered under fasted state.

  • Experimental: Treatment A
    Single oral 10 mg dose of tofacitinib MR-FAST administered in the fed state.
    Intervention: Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
  • Experimental: Treatment B:
    Single oral 10 mg dose of tofacitinib MR-SLOW administered in the fed state.
    Intervention: Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
  • Experimental: Treatment C
    Single oral 10 mg dose of tofacitinib MR-FAST administered in the fasted state.
    Intervention: Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
  • Experimental: Treatment D
    Single oral 10 mg dose of tofacitinib MR-SLOW administered in the fasted state.
    Intervention: Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
  • Experimental: Treatment E
    Single oral 10 mg dose of tofacitinib MR-MODERATE administered in the fasted state
    Intervention: Drug: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
  • Experimental: 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: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
November 15, 2017
November 15, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

    1. Achieved postmenopausal status, defined as: cessation of regular menses for at least 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 per m2; and a total body weight above 50 kg (110 lbs) for males and above 45 kg (99 lbs) for females.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Clinically significant infections within the past 3 months, 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 less than the lower limit of the reference range for the local laboratory
  • Evidence or history of cyclic neutropenia.
  • Personal or family history of hereditary immunodeficiency
  • Vaccination with live or attenuated vaccines within the 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;
  • 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 investigational product (whichever is longer).
  • Nursing females or females of childbearing potential. Male subjects who are unwilling or unable to use a condom plus a highly effective method of contraception as outlined 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 or inducers 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 heparin-induced thrombocytopenia.
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
 
 
NCT03112148
A3921261
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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.

BY PHONE

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1-800-718-1021

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Contact

[email protected]



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