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

Sponsor
Pfizer
Study ID
NCT01731327
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2012
Status verified
Dec 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental Treatment A
    A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
  • Experimental: Experimental Treatment B
    A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Primary Outcome Measure

AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized [ Time Frame: 72 hours post dose ]

Related Studies