A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers

August 12, 2009 updated by: Pfizer

A Phase I, Open Label, Fixed-Sequence Study to Estimate the Effect of Tacrolimus and Cyclosporine on the Pharmacokinetics of CP-690,550 in Healthy Volunteers

A new immunosuppressive drug, based on the inhibition of important enzymes in the immune system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many treatments for transplant rejection may be administered together, this research study will analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on the JAK inhibitor, CP-690,550.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males between 21 and 55 years, inclusive.
  • Healthy females of non-childbearing potential between 21 and 55 years, inclusive.
  • Total body weight greater than 132 pounds.

Exclusion Criteria:

  • Evidence or history of clinically significant disease
  • Females of childbearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Treatment Arm 1 will receive one single dose of CP-690,550 on Day 1, Tacrolimus on Days 1-8, and one single dose of CP-690,550 on Day 8.
Drug: CP- 690,550 and Tacrolimus
10 mg, single dose of CP-690,550 on Day 1 5 mg, every 12 hours of Tacrolimus on Days 1-8 10 mg, single dose of CP-690,550 on Day 8
Other: 2
Treatment Arm 2 will receive one single dose of CP-690,550 on Day 1, Cyclosporine on Days 1-6, and one single dose of CP-690,550 on Day 6.
Drug: CP- 690,550 and Cyclosporine
10 mg, single dose of CP-690,550 on Day 1 200 mg, every 12 hours of Cyclosporine on Days 1-6 10 mg, single dose of CP-690,550 on Day 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of multiple dose Tacrolimus and Cyclosporine on the pharmacokinetics of a single oral dose of CP-590,550 in healthy volunteers
Time Frame: 9 days
9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety and tolerability of a single oral dose of CP-690,550 when co-administered with Tacrolimus or Cyclosporine
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2009

Last Update Submitted That Met QC Criteria

August 12, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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