Trial · NCT05650333
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7 | Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose] | Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | |
| Secondary | Apparent Oral Clearance (CL/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological process. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. |
| Secondary | Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | 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. Vz/F is influenced by the fraction absorbed. |
| Secondary | Elimination Half-Life (t1/2) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | Elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by one half at the elimination phase. |
| Secondary | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline and Day 7 | |
| Secondary | Change From Baseline in T Lymphocytes on Day 7 | Baseline and Day 7 | T lymphocytes included CD3 cells, CD4 T helper lymphocytes and CD8 T cytotoxic lymphocytes. |
| Secondary | Change From Baseline in B Lymphocytes on Day 7 | Baseline and Day 7 | B lymphocytes included CD19 cells. |
| Secondary | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline and Day 7 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent were events between first dose to 35 days after last dose, that were absent before treatment or that worsened relative to pretreatment state. |
| Secondary | Number of Participants With Treatment Related AEs | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness was judged by investigator. |
| Secondary | Number of Participants With Serious AEs (SAEs) | Day 1 of dosing up to 35 days after the last dose (maximum up to Day 42) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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. |
| Secondary | Number of Participants With AEs Leading to Treatment Discontinuation | Day 1 up to Day 7 | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Day 1 up to Day 7 | Vital signs evaluation included blood pressure and heart rate measurements. Clinical significance of any vital sign abnormality was judged by investigator. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Day 1 up to Day 7 | Clinical laboratory parameters included haematology: haemoglobin, haematocrit, red blood cells count, platelet count, white blood cells count, total absolute: neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry: urea and creatinine estimated creatinine clearance, glucose (fasting), sodium, potassium, chloride, aspartate aminotransferase (AT), alanine AT, total bilirubin, alkaline phosphatase, albumin, total protein; urinalysis: local dipstick: pH, qualitative: glucose, protein, albuminuria, blood, ketones, nitrites, leukocyte esterase and others. Clinical significance of any laboratory abnormality was judged by investigator. |
| Secondary | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1 and 7 | The pediatric taste questionnaire included 3 questions regarding: 1) Overall Taste (likeability in tase), 2) Overall Mouthfeel (how the medicine felt) and 3) Overall Volume of Medicine (likeability of the amount of medicine). Each question ranged from 1 (most favorable) to 5 (least favorable), higher scores indicates less liking to medicine. Ritlecitinib was provided as capsules; for administration, the capsules were dissolved in water and the contents of the capsule in water were taken according to the dosing administration instructions. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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