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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

CP- 690,550 and Tacrolimus

Intervention Type DRUG

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

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.

Group Type OTHER

CP- 690,550 and Cyclosporine

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.