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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tofacitinib modified-release (MR) formulation

• Registration Number: NCT01731327
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Treatment A	tofacitinib modified-release (MR) formulation	A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Experimental Treatment B	tofacitinib modified-release (MR) formulation	A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore