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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: tofacitinib (CP-690,550) modified-release formulation A; Drug: tofacitinib (CP-690,550) immediate-release formulation; Drug: tofacitinib (CP-690,550) modified-release formulation B1; Drug: tofacitinib (CP-690,550) modified-release formulation B2

• Registration Number: NCT01499004
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	tofacitinib (CP-690,550) modified-release formulation A	tofacitinib (CP-690,550) modified-release formulation A-Fed
Treatment F	tofacitinib (CP-690,550) immediate-release formulation	tofacitinib (CP-690,550) immediate-release formulation-Fasted
Treatment B	tofacitinib (CP-690,550) modified-release formulation B1	tofacitinib (CP-690,550) modified-release formulation B1-Fed
Treatment C	tofacitinib (CP-690,550) modified-release formulation A	tofacitinib (CP-690,550) modified-release formulation A-Fasted
Treatment D	tofacitinib (CP-690,550) modified-release formulation B1	tofacitinib (CP-690,550) modified-release formulation B1-Fasted
Treatment E	tofacitinib (CP-690,550) modified-release formulation B2	tofacitinib (CP-690,550) modified-release formulation B2-Fasted

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation	24 hours post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore