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

NCT01710033 | Completed Phase 1 Results

• 1 other identifier: A3921007
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

CP-690,550; kidney transplant

Outcome Measures

Primary Outcomes (25)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

• Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550

  Area under the plasma concentration time-curve from zero to 12 hour concentration \[AUC(0-12)\] at steady state.

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29

• Maximum Observed Plasma Concentration (Cmax) For CP-690,550

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

• Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

• Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

• Accumulation Ratio (Rac) For CP-690,550

  Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29

• Plasma Decay Half-Life (t1/2) For CP-690,550

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

• Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.

  0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

• Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline

  Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  Screening, 0 hour (pre-dose) on Day 1

• Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8

  Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 8

• Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15

  Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 15

• Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29

  Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 29

• Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57

  Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 57

• Cyclosporine (CsA) Plasma Trough Concentration at Baseline

  The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  Screening, 0 hour (pre-dose) on Day 1

• Cyclosporine (CsA) Plasma Trough Concentration at Day 8

  CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 8

• Cyclosporine (CsA) Plasma Trough Concentration at Day 15

  CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 15

• Cyclosporine (CsA) Plasma Trough Concentration at Day 29

  CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 29

• Cyclosporine (CsA) Plasma Trough Concentration at Day 57

  CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 57

• Tacrolimus (TAC) Plasma Trough Concentration at Baseline

  The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  Screening, 0 hour (pre-dose) on Day 1

• Tacrolimus (TAC) Plasma Trough Concentration at Day 8

  TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 8

• Tacrolimus (TAC) Plasma Trough Concentration at Day 15

  TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 15

• Tacrolimus (TAC) Plasma Trough Concentration at Day 29

  TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 29

• Tacrolimus (TAC) Plasma Trough Concentration at Day 57

  TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  0 hour (pre-dose) on Day 57

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CP-690,550 5 mg BID

EXPERIMENTAL

Drug: CP-690,550 5 mg BID

CP-690,550 15 mg BID

EXPERIMENTAL

Drug: CP-690,550 15 mg BID

CP-690,550 30 mg BID

EXPERIMENTAL

Drug: CP-690,550 30 mg BID

Interventions

Placebo DRUG

Placebo tables twice daily (BID) for 28 days

Placebo

CP-690,550 5 mg BID DRUG

CP-690,550 5 mg BID for 28 days

CP-690,550 5 mg BID

CP-690,550 15 mg BID DRUG

CP-690,550 15 mg BID for 28 days

CP-690,550 15 mg BID

CP-690,550 30 mg BID DRUG

CP-690,550 30 mg BID for 28 days

CP-690,550 30 mg BID

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable kidney transplant patients 6 or more months after transplantation.
• Subjects must be on mycophenolate mofetil 1-2 gm daily
• In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

You may not qualify if:

• Any rejection episodes in the preceding 3 months.
• Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Pfizer Investigational Site

Birmingham, Alabama, 35249-6860, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35249, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294-6862, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90057, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1092, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1093, United States

Location

Pfizer Investigational Site

Livingston, New Jersey, 07039, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tofacitinib; BID protein, human

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: September 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: December 26, 2012
• Results First Posted: December 26, 2012

Record last verified: 2012-11

Locations

US (10)