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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731327

Enrollment

Registered

2012-11-21

Start date

2012-11-30

Completion date

2012-12-31

Last updated

2012-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, relative bioavailability, modified release, tofacitinib, CP-690, 550, pharmacokinetic

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.

Interventions

DRUGtofacitinib modified-release (MR) formulation

A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026