Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Other | Healthy volunteers |
|
| Mild renal impairment | Experimental | patients with mild (>50 and ≤80 mL/min) renal impairment |
|
| Moderate renal impairment | Experimental | patients with moderate (≥30 and ≤50 mL/min) renal impairment |
|
| severe renal impairment | Experimental | patients with severe (<30 mL/min) renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | 10 mg (2 x 5 mg tablets), single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose | |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
| Renal Clearance (CL R) | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. | 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24030917 | Derived | Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CP-690,550 (Mild Renal Insufficiency) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | Analysis set included all participants who received study medication. | Posted | Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | COSTART | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CP-690,550 |
| Drug |
10 mg (2 x 5 mg tablets), single dose |
|
| CP-690,550 | Drug | 10 mg (2 x 5 mg tablets), single dose |
|
| CP-690,550 | Drug | 10 mg (2 x 5 mg tablets), single dose |
|
| New Orleans |
| Louisiana |
| 70118 |
| United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70119 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55404 | United States |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Analysis set included all participants who received study medication. | Posted | Mean | Standard Deviation | ng/mL | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
|
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Analysis set included all participants who received study medication. | Posted | Median | Full Range | hours | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Analysis set included all participants who received study medication. | Posted | Mean | Standard Deviation | hours | 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose |
|
|
|
| Primary | Renal Clearance (CL R) | Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. | Analysis set included all participants who received study medication. | Posted | Mean | Standard Deviation | mL/min | 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 |
| EG002 | 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. | 0 | 6 | 3 | 6 |
| EG003 | 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. | 0 | 6 | 1 | 6 |
| Tooth disorder | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
|
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [moderate renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI. | Ratio of adjusted geometric mean | 104.17 | 2-Sided | 90 | 75.18 | 144.34 | No | Superiority or Other |
| One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [severe renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI. | Ratio of adjusted geometric mean | 117.65 | 2-Sided | 95 | 84.91 | 163.02 | No | Superiority or Other |