|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|
|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.|
|Intervention Model: Parallel Assignment|
Masking: None (Open Label)
Primary Purpose: Prevention
- 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
- 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
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.
Intervention: Drug: CP- 690,550 and Tacrolimus
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.
Intervention: Drug: CP- 690,550 and Cyclosporine
|Same as current|
|August 2009 (Final data collection date for primary outcome measure)|
- 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.
- Evidence or history of clinically significant disease
- Females of childbearing potential
|Sexes Eligible for Study:||All|
|21 Years to 55 Years (Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Director, Clinical Trial Disclosure Group, Pfizer, Inc.|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|