Trial · NCT05650333
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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] | Pharmacokinetic (PK) parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Nanogram*hours per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| 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 | PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Hours | MEDIAN |
| SECONDARY | Apparent Oral Clearance (CL/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Liter per hour (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Liter | GEOMETRIC_MEAN |
| SECONDARY | Elimination Half-Life (t1/2) of Ritlecitinib | 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7 | PK parameter analysis population: treated participants who had at least 1 of the PK parameters of primary interest. All participants with evaluable PK were included in the analysis. Two participants weren't included in analysis as they didn't have evaluable PK data (1 discontinued study intervention on Day 3 and the other had the important protocol deviation, PK samples not collected on Day 7). Number of Participants Analyzed: participants evaluable for the outcome measure. | Hours | MEAN |
| SECONDARY | Change From Baseline in Interferon Gamma Induced Protein 10 (IP-10) on Day 7 | Baseline and Day 7 | The pharmacodynamic (PD) parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows. | Picogram per milliliter (pg/mL) | MEDIAN |
| SECONDARY | Change From Baseline in T Lymphocytes on Day 7 | Baseline and Day 7 | The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows. | 10^9 cells per liter | MEDIAN |
| SECONDARY | Change From Baseline in B Lymphocytes on Day 7 | Baseline and Day 7 | The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows. | 10^6 cells per liter | MEDIAN |
| SECONDARY | Change From Baseline in Natural Killer (NK) Cells on Day 7 | Baseline and Day 7 | The PD parameter analysis population included all participants treated who had at least 1 of the PD parameters of primary interest. Here, Number Analyzed signifies number of participants evaluable for specified rows. | 10^6 cells per liter | MEDIAN |
| 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) | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs Leading to Treatment Discontinuation | Day 1 up to Day 7 | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Day 1 up to Day 7 | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Day 1 up to Day 7 | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants as Per Score for Pediatric Taste Assessment Questionnaire | Day 1 and 7 | Safety analysis set included all participants assigned to study intervention and who received at least 1 dose of study intervention. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
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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