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This is a phase 1, open label, two-arm study to assess target occupancy and functional inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3 |
|
| Cohort 2 | Experimental | Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib 50 mg | Drug | 50 mg single dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Target Occupancy for JAK3 | Target occupancy for janus kinase 3 (JAK3) in peripheral blood mononuclear cells (PBMCs) by ritlecitinib was investigated in human blood by chemical probe-based enrichment and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Percent Target Occupancy for BTK | Target occupancy for Bruton's tyrosine kinase (BTK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Percent Target Occupancy for ITK | Target occupancy forIL 2 inducible T-cell kinase (ITK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Percent Target Occupancy for TXK | Target occupancy for tyrosine kinase expressed in T cells (TXK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | Cmax is maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data. | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38267790 | Derived | Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 16 participants were assigned to study treatment; 8 in the ritlecitinib 50 mg group and 8 in the ritlecitinib 200 mg group. All the participants were treated in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | RITLECITINIB 50 MG CAPSULE | Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1. |
| FG001 | RITLECITINIB 200 MG CAPSULE | Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis population included all enrolled participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | RITLECITINIB 50 MG CAPSULE | Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1. |
| BG001 | RITLECITINIB 200 MG CAPSULE | Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1. |
| 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 | Percent Target Occupancy for JAK3 | Target occupancy for janus kinase 3 (JAK3) in peripheral blood mononuclear cells (PBMCs) by ritlecitinib was investigated in human blood by chemical probe-based enrichment and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
Baseline up to 35 days after the last dose of study treatment on Day 1 (up to 35 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RITLECITINIB 50 MG CAPSULE | Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 10, 2021 | Dec 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2021 | Dec 15, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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| Ritlecitinib 200 mg | Drug | 200 mg single dose |
|
|
| -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Percent Target Occupancy for TEC | Target occupancy for tyrosine kinase expressed carcinoma (TEC) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Percent Target Occupancy for BMX | Target occupancy for bone marrow tyrosine kinase gene in chromosome X (BMX) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point) *100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
Tmax is time for Cmax. Tmax for ritlecitinib was observed directly from data as time of first occurrence. |
| 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Last Quantifiable Plasma Concentration (Clast) of Ritlecitinib | Clast is last quantifiable plasma concentration. Clast for ritlecitinib was observed directly from data. | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib | Cav is average plasma concentration from time 0 to 24 hours over the 24 hours period. Cav for ritlecitinib was calculated as area under the plasma concentration-time curve from 0 to 24 hours (AUC24) divided by 24. | 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib | AUClast is area under the plasma concentration-time profile from time 0 to the time of the Clast. AUClast for ritlecitinib was determined using linear/log trapezoidal method. | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
| Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib | AUC24 is area under the plasma concentration-time curve from time 0 to 24 hours. AUC24 for ritlecitinib was determined using linear/log trapezoidal method. | 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose |
| Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. 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 were events between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
| Number of Participants With Treatment-Emergent Adverse Events by Severity | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. Treatment-emergent are events between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocyte, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, etc), chemistry (glucose, calcium, sodium, potassium, chloride, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, etc), and urinalysis (glucose, protein, hemoglobin, ketones, nitrite, leukocytes, urine bacteria, etc). Baseline = the pre-dose measurement on Day -1. Laboratory abnormalities meeting pre-defined criteria are reported for this outcome measure. Only those categories in which at least 1 participant had data were reported. ULN=upper limit of normal. LPF=low power field. | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
| Number of Participants With Pre-defined Criteria for Vital Signs | Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) supine DBP: less than (<) 50 mmHg, b) supine DBP: change of >= 20mmHg increase, c) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) supine SBP: <90 mmHg, b) supine SBP: change of >=30mmHg increase, c) supine SBP: change of >=30mmHg decrease; 3) Supine pulse rate, a) <40 bpm, b) >120 bpm. mmHg=millimeters of mercury, bpm=beats per minute. | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.
| OG001 | RITLECITINIB 200 MG CAPSULE | Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1. |
|
|
| Primary | Percent Target Occupancy for BTK | Target occupancy for Bruton's tyrosine kinase (BTK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Primary | Percent Target Occupancy for ITK | Target occupancy forIL 2 inducible T-cell kinase (ITK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Primary | Percent Target Occupancy for TXK | Target occupancy for tyrosine kinase expressed in T cells (TXK) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Primary | Percent Target Occupancy for TEC | Target occupancy for tyrosine kinase expressed carcinoma (TEC) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point)*100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Primary | Percent Target Occupancy for BMX | Target occupancy for bone marrow tyrosine kinase gene in chromosome X (BMX) in PBMCs by ritlecitinib was investigated in human blood by chemical probe-based enrichment and LC-MS/MS analysis. % TO is calculated as [(baseline value - value at specified time point) *100/baseline value], where baseline value in this formula is defined as the mean of the two pre-dose measurements at Hour -1 and Hour 0 on Day 1. Since (baseline value - value at specified time point)=0 at baseline, % TO at baseline is 0. | The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point. | Posted | Median | Full Range | percentage of occupancy | -1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib | Cmax is maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib | Tmax is time for Cmax. Tmax for ritlecitinib was observed directly from data as time of first occurrence. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Median | Full Range | hour (hr) | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Secondary | Last Quantifiable Plasma Concentration (Clast) of Ritlecitinib | Clast is last quantifiable plasma concentration. Clast for ritlecitinib was observed directly from data. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Secondary | Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib | Cav is average plasma concentration from time 0 to 24 hours over the 24 hours period. Cav for ritlecitinib was calculated as area under the plasma concentration-time curve from 0 to 24 hours (AUC24) divided by 24. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose |
|
|
|
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib | AUClast is area under the plasma concentration-time profile from time 0 to the time of the Clast. AUClast for ritlecitinib was determined using linear/log trapezoidal method. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose |
|
|
|
| Secondary | Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib | AUC24 is area under the plasma concentration-time curve from time 0 to 24 hours. AUC24 for ritlecitinib was determined using linear/log trapezoidal method. | The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose |
|
|
|
| Secondary | Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. 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 were events between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | The analysis population included all participants who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
|
|
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events by Severity | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. Treatment-emergent are events between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. | The analysis population included all participants who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocyte, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, etc), chemistry (glucose, calcium, sodium, potassium, chloride, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, etc), and urinalysis (glucose, protein, hemoglobin, ketones, nitrite, leukocytes, urine bacteria, etc). Baseline = the pre-dose measurement on Day -1. Laboratory abnormalities meeting pre-defined criteria are reported for this outcome measure. Only those categories in which at least 1 participant had data were reported. ULN=upper limit of normal. LPF=low power field. | The analysis population included all participants who took at least 1 dose of study treatment and with at least one observation of the given laboratory test while on study treatment or during lag time. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
|
|
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| Secondary | Number of Participants With Pre-defined Criteria for Vital Signs | Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) supine DBP: less than (<) 50 mmHg, b) supine DBP: change of >= 20mmHg increase, c) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) supine SBP: <90 mmHg, b) supine SBP: change of >=30mmHg increase, c) supine SBP: change of >=30mmHg decrease; 3) Supine pulse rate, a) <40 bpm, b) >120 bpm. mmHg=millimeters of mercury, bpm=beats per minute. | The analysis population included all participants who took at least 1 dose of study treatment and who were evaluated against criteria. | Posted | Count of Participants | Participants | From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | RITLECITINIB 200 MG CAPSULE | Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1. | 0 | 8 | 0 | 8 | 2 | 8 |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
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| 2H |
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| 4H |
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| 8H |
|
| 24H |
|
| 48H |
|
| 2H |
|
| 4H |
|
| 8H |
|
| 24H |
|
| 48H |
|
| 2H |
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| 4H |
|
| 8H |
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| 24H |
|
| 48H |
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| 2H |
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| 4H |
|
| 8H |
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| 24H |
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| 48H |
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| 2H |
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| 4H |
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| 8H |
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| 24H |
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| 48H |
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| Number of Participants with treatment-related TEAEs |
|
| Number of Participants with treatment-related SAEs |
|
| Severe (all causalities) |
|
| Mild (treatment-related) |
|
| Moderate (treatment-related) |
|
| Severe (treatment-related) |
|
| Urine Nitrite >=1 |
|
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| Urine Bacteria (/LPF) >20 |
|
|
| Supine DBP change >= 20mmHg decrease |
|
| Supine SBP <90 mmHg |
|
| Supine SBP change >=30mmHg increase |
|
| Supine SBP change >=30mmHg decrease |
|
| Supine pulse rate <40 bpm |
|
| Supine pulse rate >120 bpm |
|