A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

Study Overview
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Brief Summary
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This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.

Official Title
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A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: tofacitinib modified-release (MR) formulation
* Drug: tofacitinib modified-release (MR) formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects and/or healthy female subjects who are of non-childbearing potential. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Clinically significant infections within the past 3 months

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment A<br>A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state. | Drug: tofacitinib modified-release (MR) formulation<br>* A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.<br>|
| Experimental: Experimental Treatment B<br>A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state. | Drug: tofacitinib modified-release (MR) formulation<br>* A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized |  | 72 hours post dose | 
| Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized |  | 72 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized |  | 72 hours post dose | 
| AUCinf: Area Under the Curve From Time Zero to Infinity |  | 72 hours post dose | 
| Cmax: Maximum Observed Plasma Concentration |  | 72 hours post dose | 
| AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration |  | 72 hours post dose | 
| Tmax: Amount of time drug takes to reach Cmax |  | 72 hours post dose | 
| t ½: Terminal elimination half-life |  | 72 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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modified release, tofacitinib, CP-690, 550, pharmacokinetic, Phase 1, relative bioavailability