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Completed

NCT Number: NCT00860496

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

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Key information

Conditions

Healthy Volunteers

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP- 690,550 and Tacrolimus

Drug

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

CP- 690,550 and Cyclosporine

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 12, 2009
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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