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A Study Of CP-690,550 In Stable Kidney Transplant Patients

NCT01710033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-12-26

Study results available
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Summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Conditions

  • Kidney Transplant

Interventions

DRUG

Placebo

Placebo tables twice daily (BID) for 28 days

DRUG

CP-690,550 5 mg BID

CP-690,550 5 mg BID for 28 days

DRUG

CP-690,550 15 mg BID

CP-690,550 15 mg BID for 28 days

DRUG

CP-690,550 30 mg BID

CP-690,550 30 mg BID for 28 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710033 on ClinicalTrials.gov