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CompletedNCT01710033Updated Dec 26, 2012Results posted

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

A Phase 1 interventional study of Placebo and CP-690,550 5 mg BID in Kidney Transplant, sponsored by Pfizer. Completed at 11 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-12-26.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Transplant

Keywords

  • CP-690,550
  • kidney transplant
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Any rejection episodes in the preceding 3 months.
  • Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    CP-690,550 5 mg BID

    Drug: CP-690,550 5 mg BID

  • Experimental
    CP-690,550 15 mg BID

    Drug: CP-690,550 15 mg BID

  • Experimental
    CP-690,550 30 mg BID

    Drug: CP-690,550 30 mg BID

Interventions

06

What researchers measure

Primary outcomes

  1. 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).

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

  2. 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.

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

  3. 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.

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

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

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

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

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

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

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

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

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

  8. Accumulation Ratio (Rac) For CP-690,550

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

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

    Time frame: 0 hour (pre-dose) on Day 8

  13. 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.

    Time frame: 0 hour (pre-dose) on Day 15

  14. 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.

    Time frame: 0 hour (pre-dose) on Day 29

  15. 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.

    Time frame: 0 hour (pre-dose) on Day 57

  16. 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.

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

  17. 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.

    Time frame: 0 hour (pre-dose) on Day 8

  18. 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.

    Time frame: 0 hour (pre-dose) on Day 15

  19. 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.

    Time frame: 0 hour (pre-dose) on Day 29

  20. 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.

    Time frame: 0 hour (pre-dose) on Day 57

  21. 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.

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

  22. 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.

    Time frame: 0 hour (pre-dose) on Day 8

  23. 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.

    Time frame: 0 hour (pre-dose) on Day 15

  24. 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.

    Time frame: 0 hour (pre-dose) on Day 29

  25. 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.

    Time frame: 0 hour (pre-dose) on Day 57

07

Results

Posted Dec 26, 2012

Participant flow

Stage 1
Participant flow — Stage 1
MilestonePlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1CP-690,550 30 mg, Stage 2
Started66660
Completed66660
Not completed00000
Stage 2
Participant flow — Stage 2
MilestonePlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1CP-690,550 30 mg, Stage 2
Started00004
Completed00003
Not completed00001
Withdrew: Adverse event00001

Outcome measures

PrimaryArea 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).

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Reported as:
Mean · nanogram*hour per milliliter (ng*hr/mL)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550
nanogram*hour per milliliter (ng*hr/mL)CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550183 ± 75.3754 ± 1821200 ± 266
PrimaryArea 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.

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Reported as:
Mean · ng*hr/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550
ng*hr/mLCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550319 ± 1751300 ± 2411560 ± 311
PrimaryArea 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.

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
Reported as:
Mean · ng*hr/mL
Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550
ng*hr/mLCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550273 ± 1321090 ± 1501420 ± 253
PrimaryMaximum Observed Plasma Concentration (Cmax) For CP-690,550
Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Reported as:
Mean · nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) For CP-690,550
nanogram per milliliter (ng/mL)CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Maximum Observed Plasma Concentration (Cmax) For CP-690,55041.0 ± 14.9140 ± 34.5325 ± 113
PrimaryMaximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Reported as:
Mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
ng/mLCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,55052.2 ± 15.2220 ± 39.4351 ± 46.3
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Reported as:
Median · hours
Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
hoursCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,5500.75 (0.50 to 2.00)1.50 (0.50 to 2.00)0.50 (0.50 to 2.00)
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Reported as:
Median · hours
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
hoursCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,5500.75 (0.50 to 2.00)0.50 (0.50 to 1.00)0.50 (0.50 to 1.00)
PrimaryAccumulation Ratio (Rac) For CP-690,550

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

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
Reported as:
Mean · ratio
Accumulation Ratio (Rac) For CP-690,550
ratioCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Accumulation Ratio (Rac) For CP-690,5501.48 ± 0.4671.39 ± 0.2451.22 ± 0.182
PrimaryPlasma 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.

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
Reported as:
Mean · hours
Plasma Decay Half-Life (t1/2) For CP-690,550
hoursCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Plasma Decay Half-Life (t1/2) For CP-690,5503.36 ± 0.869NA ± NA2.94 ± 0.620
PrimaryPlasma 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.

Time frame:
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
Reported as:
Mean · hours
Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550
hoursCP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Plasma Decay Half-Life (t1/2) at Steady State For CP-690,5505.18 ± 2.005.15 ± 1.123.71 ± 0.201
PrimaryMycophenolic 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.

Time frame:
Screening, 0 hour (pre-dose) on Day 1
Reported as:
Mean · Milligram per Liter (mg/L)
Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline
Milligram per Liter (mg/L)Placebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline2.73 ± 1.232.18 ± 1.801.84 ± 1.132.43 ± 1.80
PrimaryMycophenolic 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.

Time frame:
0 hour (pre-dose) on Day 8
Reported as:
Mean · mg/L
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8
mg/LPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 83.25 ± 2.772.11 ± 2.011.29 ± 0.482.56 ± 1.62
PrimaryMycophenolic 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.

Time frame:
0 hour (pre-dose) on Day 15
Reported as:
Mean · mg/L
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15
mg/LPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 153.15 ± 1.752.36 ± 2.211.48 ± 0.632.74 ± 1.52
PrimaryMycophenolic 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.

Time frame:
0 hour (pre-dose) on Day 29
Reported as:
Mean · mg/L
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29
mg/LPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 292.61 ± 1.772.68 ± 2.004.30 ± 3.883.24 ± 1.71
PrimaryMycophenolic 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.

Time frame:
0 hour (pre-dose) on Day 57
Reported as:
Mean · mg/L
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57
mg/LPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 572.60 ± 1.562.89 ± 2.751.75 ± 1.102.67 ± 1.87
PrimaryCyclosporine (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.

Time frame:
Screening, 0 hour (pre-dose) on Day 1
Reported as:
Mean · ng/mL
Cyclosporine (CsA) Plasma Trough Concentration at Baseline
ng/mLPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1
Cyclosporine (CsA) Plasma Trough Concentration at Baseline249.50 ± NA81.00 ± 41.99173.00 ± 51.11
PrimaryCyclosporine (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.

Time frame:
0 hour (pre-dose) on Day 8
Reported as:
Mean · ng/mL
Cyclosporine (CsA) Plasma Trough Concentration at Day 8
ng/mLPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1
Cyclosporine (CsA) Plasma Trough Concentration at Day 8137.00 ± NA77.25 ± 47.28134.00 ± 17.78
PrimaryCyclosporine (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.

Time frame:
0 hour (pre-dose) on Day 15
Reported as:
Mean · ng/mL
Cyclosporine (CsA) Plasma Trough Concentration at Day 15
ng/mLPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1
Cyclosporine (CsA) Plasma Trough Concentration at Day 15207.00 ± NA86.60 ± 43.71160.33 ± 24.58
PrimaryCyclosporine (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.

Time frame:
0 hour (pre-dose) on Day 29
Reported as:
Mean · ng/mL
Cyclosporine (CsA) Plasma Trough Concentration at Day 29
ng/mLPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1
Cyclosporine (CsA) Plasma Trough Concentration at Day 29226.00 ± NA96.00 ± 53.43125.00 ± 22.34
PrimaryCyclosporine (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.

Time frame:
0 hour (pre-dose) on Day 57
Reported as:
Mean · ng/mL
Cyclosporine (CsA) Plasma Trough Concentration at Day 57
ng/mLPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1
Cyclosporine (CsA) Plasma Trough Concentration at Day 57292.00 ± NA91.20 ± 72.71152.00 ± 43.28
PrimaryTacrolimus (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.

Time frame:
Screening, 0 hour (pre-dose) on Day 1
Reported as:
Mean · ng/mL
Tacrolimus (TAC) Plasma Trough Concentration at Baseline
ng/mLPlacebo, Stage 1CP-690,550 15 mg, Stage 1
Tacrolimus (TAC) Plasma Trough Concentration at Baseline6.75 ± 2.477.17 ± 1.76
PrimaryTacrolimus (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.

Time frame:
0 hour (pre-dose) on Day 8
Reported as:
Mean · ng/mL
Tacrolimus (TAC) Plasma Trough Concentration at Day 8
ng/mLPlacebo, Stage 1CP-690,550 15 mg, Stage 1
Tacrolimus (TAC) Plasma Trough Concentration at Day 87.50 ± 2.128.00 ± 1.00
PrimaryTacrolimus (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.

Time frame:
0 hour (pre-dose) on Day 15
Reported as:
Mean · ng/mL
Tacrolimus (TAC) Plasma Trough Concentration at Day 15
ng/mLPlacebo, Stage 1CP-690,550 15 mg, Stage 1
Tacrolimus (TAC) Plasma Trough Concentration at Day 158.00 ± 2.836.67 ± 2.08
PrimaryTacrolimus (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.

Time frame:
0 hour (pre-dose) on Day 29
Reported as:
Mean · ng/mL
Tacrolimus (TAC) Plasma Trough Concentration at Day 29
ng/mLPlacebo, Stage 1CP-690,550 15 mg, Stage 1
Tacrolimus (TAC) Plasma Trough Concentration at Day 297.00 ± 2.8312.67 ± 4.51
PrimaryTacrolimus (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.

Time frame:
0 hour (pre-dose) on Day 57
Reported as:
Mean · ng/mL
Tacrolimus (TAC) Plasma Trough Concentration at Day 57
ng/mLPlacebo, Stage 1CP-690,550 15 mg, Stage 1
Tacrolimus (TAC) Plasma Trough Concentration at Day 575.00 ± 1.416.33 ± 0.58

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo, Stage 1—1/6 (16.7%)5/6 (83.3%)
CP-690,550 5 mg, Stage 1—0/6 (0%)5/6 (83.3%)
CP-690,550 15 mg, Stage 1—2/6 (33.3%)5/6 (83.3%)
CP-690,550 30 mg, Stage 1 And 2—1/10 (10%)8/10 (80%)
Most frequent serious events
Most frequent serious events
EventPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
GastroenteritisInfections and infestations0/60/62/60/10
Urinary tract infectionInfections and infestations1/60/61/60/10
Blood creatinine increasedInvestigations0/60/61/60/10
Viral infectionInfections and infestations0/60/60/61/10
DehydrationMetabolism and nutrition disorders0/60/60/61/10
Most frequent other events
Showing 10 of 51
Most frequent other events
EventPlacebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2
HeadacheNervous system disorders1/63/60/61/10
AnaemiaBlood and lymphatic system disorders0/60/62/61/10
Abdominal painGastrointestinal disorders0/62/60/60/10
BronchitisInfections and infestations0/62/60/60/10
VertigoEar and labyrinth disorders0/60/60/62/10
DyspepsiaGastrointestinal disorders0/60/60/62/10
Herpes simplexInfections and infestations0/60/61/62/10
LeukocytosisBlood and lymphatic system disorders0/60/61/60/10
Conjunctival haemorrhageEye disorders0/60/61/60/10
Abdominal pain lowerGastrointestinal disorders1/60/60/60/10

Baseline characteristics

Age Continuous
Age Continuous(years)Placebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2Total
Mean54.5 ± 15.053.0 ± 15.546.0 ± 17.854.2 ± 14.352.3 ± 15.0
Sex: Female, Male
Sex: Female, Male(Participants)Placebo, Stage 1CP-690,550 5 mg, Stage 1CP-690,550 15 mg, Stage 1CP-690,550 30 mg, Stage 1 And 2Total
Female21328
Male453820
08

Study locations

11 sites
  • Pfizer Investigational Site
    Birmingham, Alabama 35249-6860, United States
  • Pfizer Investigational Site
    Birmingham, Alabama 35249, United States
  • Pfizer Investigational Site
    Birmingham, Alabama 35294-6862, United States
  • Pfizer Investigational Site
    Los Angeles, California 90057, United States
  • Pfizer Investigational Site
    Indianapolis, Indiana 46202, United States
  • Pfizer Investigational Site
    Minneapolis, Minnesota 55404, United States
  • Pfizer Investigational Site
    St Louis, Missouri 63110-1092, United States
  • Pfizer Investigational Site
    St Louis, Missouri 63110-1093, United States
  • Pfizer Investigational Site
    Livingston, New Jersey 07039, United States
  • Pfizer Investigational Site
    Madison, Wisconsin 53792, United States
  • Pfizer Investigational Site
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01710033
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 18, 2012
Start date
Sep 2003
Primary completion
Apr 2005
Completion
Apr 2005
Results posted
Dec 26, 2012
Last update
Dec 26, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tofacitinib

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