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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tofacitinib tablet; Drug: Tofacitinib Oral Solution

• Registration Number: NCT04111614
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Study Start: 2019-10-11
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Tofacitinib Oral Solution	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
Arm 2	Tofacitinib Oral Solution	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
Arm 1	Tofacitinib tablet	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
Arm 2	Tofacitinib tablet	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

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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
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).
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
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
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.

Trial Locations

Locations (1)

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States