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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860496

Enrollment

Registered

2009-03-12

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Immunosuppression, JAK3 inhibitor, calcineurin inhibitors, tacrolimus, cyclosporine, pharmacokinetics, safety, tolerability

Brief summary

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.

Interventions

DRUGCP- 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

DRUGCP- 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

Study design

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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	9 days

Secondary

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026