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

Pfizer24 enrolled

Overview

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 Type

INTERVENTIONAL

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

CP- 690,550 and TacrolimusDRUG

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

CP- 690,550 and CyclosporineDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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