PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation
NCT04403776
ABOUT THIS STUDY
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- Subjects must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
- Healthy male and/or female subjects of non-childbearing potential
- Female subjects of non-childbearing potential must meet at least one of the following criteria:
- Achieved postmenopausal status, defined as follows: 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;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure.
- Body Mass Index (BMI) of 19.0 to 26.0 kg/m2; and a total body weight >50 kg (110 lbs).
Subjects presenting with any of the following will not be included in the study:
- 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 prior to first dosing (eg,
those requiring hospitalization or parenteral antibiotics, or as judged by the
Investigator), evidence of any infection within the past 7 days prior to first dosing,
history of disseminated herpes simplex infection or recurrent (>1 episode) or
disseminated herpes zoster.
- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,
etc.).
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation | ||||||
Official Title ICMJE | A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate Single Dose And Steady State PK And Bioavailability Between A Modified Release Tofacitinib (11 Mg QD) And The Immediate Release Tofacitinib (5 Mg BID) In Chinese Healthy Subjects | ||||||
Brief Summary | A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11 mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice daily) of tofacitinib in Chinese healthy subjects under fasted conditions. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Subjects will be randomized to one of the two treatment sequences. Each treatment sequence will consist of two periods, separated by a washout phase of no less than 72 hours from the AM dose on Day 7. Treatment A (Test): Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. Treatment B (Reference): Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7. Primary Purpose: Other | ||||||
Condition ICMJE | Healthy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 26 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | February 12, 2019 | ||||||
Actual Primary Completion Date | February 12, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
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Sex/Gender ICMJE |
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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 | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04403776 | ||||||
Other Study ID Numbers ICMJE | A3921213 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |