Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01513902|
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : July 4, 2016
Last Update Posted : July 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Drug: CP-690,550||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Open-label Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Pediatric Patients From 2 To Less Than 18 Years Of Age With Juvenile Idiopathic Arthritis (JIA)|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Cohort 1
Ages 12 to less than 18
CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5
Other Name: Tofacitinib
Experimental: Cohort 2
Ages 6 to less than 12
CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5
Other Name: Tofacitinib
Experimental: Corhort 3
Ages 2 to less than 6
CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing <30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5
Other Name: Tofacitinib
- Apparent Oral Clearance (CL/F) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities [ Time Frame: Baseline up to 28 days after the last dose of study drug (Day 5) ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.
- Number of Participants With Laboratory Test Abnormalities [ Time Frame: Baseline up to Day 5 ]Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).
- Number of Participants With Clinically Significant Vital Signs Abnormalities [ Time Frame: Baseline up to Day 5 ]Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]
- Apparent Volume of Distribution (Vz/F) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
- Plasma Decay Half-Life (t1/2) [ Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Taste Assessment [ Time Frame: Day 1, Day 5 ]Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513902
|United States, Minnesota|
|Explorer Clinic, University of Minnesota Children's Hospital|
|Minneapolis, Minnesota, United States, 55454|
|Clinical and Translational Science Institute Masonic Clinical Research Unit (Administration Only)|
|Minneapolis, Minnesota, United States, 55455|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Oregon|
|Randall Children's Hospital at Legacy Emanuel|
|Portland, Oregon, United States, 97227|
|PRI - Pediatric Rheumatology Research Institute GmbH|
|Bad Bramstedt, Germany, 24576|
|Hamburger Zentrum fuer Kinder-und Jugendrheumatologie SchoenKlinik Hamburg Eilbek|
|Hamburg, Germany, 22081|
|Asklepios Klinik Sankt Augustin Gmbh|
|St. Augustin, Germany, 53757|
|Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie|
|Krakow, Poland, 31-503|
|Klinika Kardiologii i Reumatologii Dzieciecej|
|Lodz, Poland, 91-738|
|Narodny ustav reumatickych chorob|
|Piestany, Slovakia, 921 12|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|