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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CP- 690,550 and Tacrolimus; Drug: CP- 690,550 and Cyclosporine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860496

A3921020

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

1

Other group

Description:

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.

Treatment:

Drug: CP- 690,550 and Tacrolimus

2

Other group

Description:

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.

Treatment:

Drug: CP- 690,550 and Cyclosporine