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

Pfizer1 site in 1 country24 target enrollmentSeptember 11, 2017

ConditionsHealthy

Interventions10 mg dose MR formulations,10 mg dose of tofacitinib IR solution

Drugs10 mg dose MR formulations,10 mg dose of tofacitinib IR solution

Overview

Phase: Phase 1
Intervention: 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 24
Locations: 1
Primary Endpoint: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (AUCinf )
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2017

End Date

November 15, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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:
•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;
•Have undergone a documented hysterectomy and/or bilateral oophorectomy;
•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.