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NCT Number: NCT04111614

A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.

This is a Phase 1, randomized, open label, 2 period, 2 sequence, cross over, single dose study to evaluate the AUC equivalence, and safety of tofacitinib 5 mL oral solution (1 mg/mL) and 5 mg tablet in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female (non-childbearing potential) participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 5 days and 4 nights (including Period 1 and Period 2).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants of non childbearing potential must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
  • Male and female participants of non-childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure (BP), pulse rate, oral temperature, and 12 lead electrocardiogram (ECG).
  • Body mass index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight greater than 50 kg (110 lb).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, 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 the baseline visit (for example, those requiring hospitalization or parenteral antibiotics, or as judged by the investigator), evidence of any infection within the past 7 days prior to the baseline visit, history of disseminated herpes simplex infection or recurrent (>1 episode) herpes zoster or disseminated herpes zoster.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • 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.
  • A positive urine drug test.

Treatment and study plan

Tofacitinib tablet

Drug

Single dose of tofacitinib 5 mg tablet

Tofacitinib Oral Solution

Drug

Single 5 mL dose of tofacitinib oral solution (1 mg/mL)

Primary outcomes

  1. AUCinf for tofacitinib oral solution and tofacitinib tablet

    Time frame: 24 hrs after study drug administration in Period 1 and Period 2

    Area under the curve from time zero to extrapolated infinite time for both oral solution and tofacitinib.

  2. AUClast for tofacitinib oral solution and tofacitinib tablet

    Time frame: 24 hrs after study drug administration in Period 1 and Period 2

    Area under the plasma concentration time curve from 0 to time of the last measurement of both the tofacitinib oral solution and tofacitinib tablet.

Secondary outcomes

  1. Cmax for tofacitinib oral solution and tofacitinib tablet

    Time frame: 24 hrs after study drug administration in Period 1 and Period 2

    Maximum observed plasma concentration for tofacitinib oral solution and tofacitinib tablet

  2. Number of subjects with adverse events (AEs).

    Time frame: Screening to up to 28-35 days after the last dose of study medication in Period 2.

    Number of subjects with adverse events (AEs).

  3. Number of subjects with laboratory tests findings of potential clinical importance

    Time frame: Screening through Day 2 of Period 2

    Number of subjects with laboratory tests findings of potential clinical importance

  4. Number of subjects with clinically significant abnormal vital signs

    Time frame: Screening through Day 2 of Period 2

    Number of subjects with clinically significant abnormal vital signs

  5. Number of subjects with clinically significant physical examination findings

    Time frame: Screening to Day 2 of Period 2

    Number of subjects with clinically significant physical examination findings.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN LABEL, 2 PERIOD, CROSS OVER, SINGLE DOSE STUDY TO DEMONSTRATE THE AREA UNDER THE CURVE EQUIVALENCE BETWEEN TOFACITINIB ORAL SOLUTION FORMULATION AND TABLET FORMULATION UNDER FASTED CONDITION IN HEALTHY PARTICIPANTS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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