NCT01731327CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental Treatment A
Experimental
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Intervention: tofacitinib modified-release (MR) formulation (Drug)
Experimental Treatment B
Experimental
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Intervention: tofacitinib modified-release (MR) formulation (Drug)
Outcomes
Primary Outcomes
AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
Time Frame: 72 hours post dose
Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
Time Frame: 72 hours post dose
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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