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

NCT04111614 | Completed Phase 1 FDA Drug

• 1 other identifier: A3921354
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCinf for tofacitinib oral solution and tofacitinib tablet

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

  24 hrs after study drug administration in Period 1 and Period 2

• AUClast for tofacitinib oral solution and tofacitinib tablet

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

  24 hrs after study drug administration in Period 1 and Period 2

Secondary Outcomes (5)

• Cmax for tofacitinib oral solution and tofacitinib tablet

  24 hrs after study drug administration in Period 1 and Period 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 laboratory tests findings of potential clinical importance

  Screening through Day 2 of Period 2

• Number of subjects with clinically significant abnormal vital signs

  Screening through Day 2 of Period 2

• Number of subjects with clinically significant physical examination findings

  Screening to Day 2 of Period 2

Study Arms (2)

Arm 1

EXPERIMENTAL

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; Drug: Tofacitinib Oral Solution

Arm 2

EXPERIMENTAL

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; Drug: Tofacitinib Oral Solution

Interventions

Tofacitinib tablet DRUG

Single dose of tofacitinib 5 mg tablet

Arm 1; Arm 2

Tofacitinib Oral Solution DRUG

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

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.

  PMID: 38298058 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tofacitinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 1, 2019
• Study Start: October 11, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)