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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00860496

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: CP- 690,550 and Tacrolimus Drug: CP- 690,550 and Cyclosporine	Phase I

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	June 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.	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

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860496

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921020
Study First Received:	March 11, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00860496 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Cyclosporine
Immunologic Factors
Clotrimazole
Miconazole
Antifungal Agents
Tioconazole

Tacrolimus
Healthy
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Tacrolimus

Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009