A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) 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 a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

Official Title
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A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: tofacitinib (CP-690,550) modified-release formulation A
* Drug: tofacitinib (CP-690,550) modified-release formulation B1
* Drug: tofacitinib (CP-690,550) modified-release formulation A
* Drug: tofacitinib (CP-690,550) modified-release formulation B1
* Drug: tofacitinib (CP-690,550) modified-release formulation B2
* Drug: tofacitinib (CP-690,550) immediate-release formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects and/or healthy females 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: Treatment A<br>tofacitinib (CP-690,550) modified-release formulation A-Fed | Drug: tofacitinib (CP-690,550) modified-release formulation A<br>* A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.<br>|
| Experimental: Treatment B<br>tofacitinib (CP-690,550) modified-release formulation B1-Fed | Drug: tofacitinib (CP-690,550) modified-release formulation B1<br>* A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food<br>|
| Experimental: Treatment C<br>tofacitinib (CP-690,550) modified-release formulation A-Fasted | Drug: tofacitinib (CP-690,550) modified-release formulation A<br>* A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food<br>|
| Experimental: Treatment D<br>tofacitinib (CP-690,550) modified-release formulation B1-Fasted | Drug: tofacitinib (CP-690,550) modified-release formulation B1<br>* A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food<br>|
| Experimental: Treatment E<br>tofacitinib (CP-690,550) modified-release formulation B2-Fasted | Drug: tofacitinib (CP-690,550) modified-release formulation B2<br>* A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food<br>|
| Experimental: Treatment F<br>tofacitinib (CP-690,550) immediate-release formulation-Fasted | Drug: tofacitinib (CP-690,550) immediate-release formulation<br>* A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time |  | 72 hours post dose | 
| AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration |  | 72 hours post dose | 
| Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) |  | 72 hours post dose | 
| Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration |  | 72 hours post dose | 
| t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma |  | 72 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation |  | 24 hours post dose | 

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