Trial Outcomes & Findings for Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function (NCT NCT01740362)
NCT ID: NCT01740362
Last Updated: 2013-01-07
Results Overview
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Results posted on
2013-01-07
Participant Flow
Participant milestones
| Measure |
CP-690,550 (Normal Renal Function)
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Baseline characteristics by cohort
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
50.8 years
STANDARD_DEVIATION 9.7 • n=93 Participants
|
61.2 years
STANDARD_DEVIATION 2.8 • n=4 Participants
|
53.5 years
STANDARD_DEVIATION 11.1 • n=27 Participants
|
59.0 years
STANDARD_DEVIATION 14.6 • n=483 Participants
|
56.1 years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dosePopulation: Analysis set included all participants who received study medication.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
268 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 71.5
|
370 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 109
|
396 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 154
|
615 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 214
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dosePopulation: Analysis set included all participants who received study medication.
Outcome measures
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
94.2 ng/mL
Standard Deviation 25.3
|
87.3 ng/mL
Standard Deviation 23.2
|
104 ng/mL
Standard Deviation 47.5
|
111 ng/mL
Standard Deviation 28.6
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dosePopulation: Analysis set included all participants who received study medication.
Outcome measures
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.75 hours
Interval 0.5 to 1.5
|
1.00 hours
Interval 0.5 to 1.5
|
0.75 hours
Interval 0.5 to 2.0
|
0.75 hours
Interval 0.5 to 1.5
|
PRIMARY outcome
Timeframe: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dosePopulation: Analysis set included all participants who received study medication.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
2.37 hours
Standard Deviation 0.363
|
2.83 hours
Standard Deviation 0.857
|
2.88 hours
Standard Deviation 0.653
|
3.77 hours
Standard Deviation 0.480
|
PRIMARY outcome
Timeframe: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dosePopulation: Analysis set included all participants who received study medication.
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.
Outcome measures
| Measure |
CP-690,550 (Normal Renal Function)
n=6 Participants
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 Participants
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 Participants
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 Participants
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Renal Clearance (CL R)
|
113 mL/min
Standard Deviation 16.2
|
84.7 mL/min
Standard Deviation 28.7
|
27.4 mL/min
Standard Deviation 15.9
|
19.9 mL/min
Standard Deviation 7.52
|
Adverse Events
CP-690,550 (Normal Renal Function)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CP-690,550 (Mild Renal Insufficiency)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CP-690,550 (Moderate Renal Insufficiency)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CP-690,550 (Severe Renal Insufficiency)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CP-690,550 (Normal Renal Function)
n=6 participants at risk
Participants with normal renal function who had creatinine clearance greater than (\>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
|
CP-690,550 (Mild Renal Insufficiency)
n=6 participants at risk
Participants with mild renal insufficiency who had creatinine clearance \>50 mL/min but less than or equal to (=\<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Moderate Renal Insufficiency)
n=6 participants at risk
Participants with moderate renal insufficiency who had creatinine clearance \>=30 mL/min but =\<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
CP-690,550 (Severe Renal Insufficiency)
n=6 participants at risk
Participants with severe renal insufficiency who had creatinine clearance \<30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER