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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

NCT01499004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-01-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

tofacitinib (CP-690,550) modified-release formulation A

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.

DRUG

tofacitinib (CP-690,550) modified-release formulation B1

A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food

DRUG

tofacitinib (CP-690,550) modified-release formulation A

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food

DRUG

tofacitinib (CP-690,550) modified-release formulation B1

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food

DRUG

tofacitinib (CP-690,550) modified-release formulation B2

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food

DRUG

tofacitinib (CP-690,550) immediate-release formulation

A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499004 on ClinicalTrials.gov