MedDataX Logo

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

NCT ID: NCT01731327

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Treatment A

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

Group Type EXPERIMENTAL

tofacitinib modified-release (MR) formulation

Intervention Type DRUG

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

Experimental Treatment B

A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Group Type EXPERIMENTAL

tofacitinib modified-release (MR) formulation

Intervention Type DRUG

A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tofacitinib modified-release (MR) formulation

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

Intervention Type DRUG

tofacitinib modified-release (MR) formulation

A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Singapore, Singapore, Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921132&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Pharmacokinetics%20%28PK%29%2C%20Safety%2C%20And%20Bioavailability%20Of%20A%20Modified-Release%20%28MR%29%20Formulation%20Of%20T

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A3921132

Identifier Type: -

Identifier Source: org_study_id