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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CP- 690,550 and Tacrolimus; Drug: CP- 690,550 and Cyclosporine

• Registration Number: NCT00860496
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-06
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CP- 690,550 and Tacrolimus	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.
2	CP- 690,550 and Cyclosporine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore