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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04111614
Collaborator
(none)
12
1
2
2
5.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Tofacitinib tablet
  • Drug: Tofacitinib Oral Solution
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 11, 2019
Actual Primary Completion Date :
Dec 12, 2019
Actual Study Completion Date :
Dec 12, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Single dose of 5 mL tofacitinib oral solution on Day 1 of Period 1 and Singe dose of 5 mg tofacitinib tablet on Day 1 of Period 2

Drug: Tofacitinib tablet
Single dose of tofacitinib 5 mg tablet

Drug: Tofacitinib Oral Solution
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)

Experimental: Arm 2

Single dose of 5 mg tofacitinib tablet on Day 1 of Period 1 and Singe dose of 5 mL tofacitinib oral solution on Day 1 of Period 2

Drug: Tofacitinib tablet
Single dose of tofacitinib 5 mg tablet

Drug: Tofacitinib Oral Solution
Single 5 mL dose of tofacitinib oral solution (1 mg/mL)

Outcome Measures

Primary Outcome Measures

  1. AUCinf for tofacitinib oral solution and tofacitinib tablet [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 [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 Outcome Measures

  1. Cmax for tofacitinib oral solution and tofacitinib tablet [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). [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 [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 [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 [Screening to Day 2 of Period 2]

    Number of subjects with clinically significant physical examination findings.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Haven Clinical Research Unit New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04111614
Other Study ID Numbers:
  • A3921354
First Posted:
Oct 1, 2019
Last Update Posted:
Jan 13, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2020