Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT05128058
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Target Occupancy Study With Ritlecitinib.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614924', 'term': 'PF-06651600'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 35 days after the last dose of study treatment on Day 1 (up to 35 days)', 'eventGroups': [{'id': 'EG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Target Occupancy for JAK3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '72.41', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '98.0'}, {'value': '28.74', 'groupId': 'OG001', 'lowerLimit': '-5.8', 'upperLimit': '51.1'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '12.28', 'groupId': 'OG000', 'lowerLimit': '-30.1', 'upperLimit': '39.5'}, {'value': '64.14', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '75.0'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '-1.39', 'groupId': 'OG000', 'lowerLimit': '-19.6', 'upperLimit': '5.2'}, {'value': '62.06', 'groupId': 'OG001', 'lowerLimit': '45.3', 'upperLimit': '73.9'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '-23.34', 'groupId': 'OG000', 'lowerLimit': '-49.1', 'upperLimit': '17.7'}, {'value': '58.76', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '65.2'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '-24.72', 'groupId': 'OG000', 'lowerLimit': '-58.2', 'upperLimit': '-10.2'}, {'value': '37.08', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '53.1'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '-25.34', 'groupId': 'OG000', 'lowerLimit': '-51.8', 'upperLimit': '3.7'}, {'value': '33.44', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '52.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percent Target Occupancy for BTK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '98.45', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '99.8'}, {'value': '99.57', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '99.8'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '96.83', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '99.2'}, {'value': '99.37', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '96.43', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '99.1'}, {'value': '99.35', 'groupId': 'OG001', 'lowerLimit': '99.2', 'upperLimit': '99.8'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '93.52', 'groupId': 'OG000', 'lowerLimit': '85.3', 'upperLimit': '97.8'}, {'value': '99.21', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '99.5'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '83.21', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '86.3'}, {'value': '92.13', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '95.5'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '69.86', 'groupId': 'OG000', 'lowerLimit': '63.3', 'upperLimit': '76.4'}, {'value': '82.66', 'groupId': 'OG001', 'lowerLimit': '75.8', 'upperLimit': '88.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': "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.", 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percent Target Occupancy for ITK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '94.40', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '100.0'}, {'value': '97.03', 'groupId': 'OG001', 'lowerLimit': '73.8', 'upperLimit': '98.0'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '67.77', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '88.4'}, {'value': '97.06', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '98.1'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '57.54', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '73.9'}, {'value': '92.27', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '97.4'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '28.76', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '58.0'}, {'value': '76.59', 'groupId': 'OG001', 'lowerLimit': '60.0', 'upperLimit': '88.9'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '-16.77', 'groupId': 'OG000', 'lowerLimit': '-42.1', 'upperLimit': '30.5'}, {'value': '32.33', 'groupId': 'OG001', 'lowerLimit': '12.4', 'upperLimit': '43.8'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '-9.87', 'groupId': 'OG000', 'lowerLimit': '-61.0', 'upperLimit': '21.6'}, {'value': '20.62', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '44.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percent Target Occupancy for TXK', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '100.0'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '100.0'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '44.97', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '66.7'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '34.01', 'groupId': 'OG000', 'lowerLimit': '-15.8', 'upperLimit': '52.1'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '100.0'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '23.17', 'groupId': 'OG000', 'lowerLimit': '-41.0', 'upperLimit': '60.7'}, {'value': '82.46', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-43.4', 'upperLimit': '31.4'}, {'value': '49.70', 'groupId': 'OG001', 'lowerLimit': '33.2', 'upperLimit': '59.7'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '-38.98', 'groupId': 'OG000', 'lowerLimit': '-83.7', 'upperLimit': '17.7'}, {'value': '20.34', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '58.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percent Target Occupancy for TEC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '96.50', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '100.0'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '94.60', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '98.0'}, {'value': '99.42', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '100.0'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '94.23', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '98.3'}, {'value': '98.78', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '93.12', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '98.6'}, {'value': '99.57', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '100.0'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '90.64', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '95.8'}, {'value': '96.85', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '97.8'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '82.48', 'groupId': 'OG000', 'lowerLimit': '75.7', 'upperLimit': '87.3'}, {'value': '92.32', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '94.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Percent Target Occupancy for BMX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': '1H', 'categories': [{'measurements': [{'value': '67.51', 'groupId': 'OG000', 'lowerLimit': '-16.4', 'upperLimit': '96.0'}, {'value': '99.13', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '100.0'}]}]}, {'title': '2H', 'categories': [{'measurements': [{'value': '85.26', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '100.0'}, {'value': '92.53', 'groupId': 'OG001', 'lowerLimit': '88.7', 'upperLimit': '100.0'}]}]}, {'title': '4H', 'categories': [{'measurements': [{'value': '84.93', 'groupId': 'OG000', 'lowerLimit': '76.0', 'upperLimit': '100.0'}, {'value': '92.26', 'groupId': 'OG001', 'lowerLimit': '87.7', 'upperLimit': '100.0'}]}]}, {'title': '8H', 'categories': [{'measurements': [{'value': '87.08', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '95.3'}, {'value': '92.48', 'groupId': 'OG001', 'lowerLimit': '85.0', 'upperLimit': '98.7'}]}]}, {'title': '24H', 'categories': [{'measurements': [{'value': '68.13', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '87.9'}, {'value': '91.32', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '97.9'}]}]}, {'title': '48H', 'categories': [{'measurements': [{'value': '26.50', 'groupId': 'OG000', 'lowerLimit': '-15.6', 'upperLimit': '54.1'}, {'value': '62.34', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '79.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'percentage of occupancy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with non-misssing value at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '297.1', 'spread': '51', 'groupId': 'OG000'}, {'value': '1275', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Cmax is maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data.', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Tmax is time for Cmax. Tmax for ritlecitinib was observed directly from data as time of first occurrence.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Last Quantifiable Plasma Concentration (Clast) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.812', 'spread': '87', 'groupId': 'OG000'}, {'value': '4.036', 'spread': '666', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Clast is last quantifiable plasma concentration. Clast for ritlecitinib was observed directly from data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.42', 'spread': '51', 'groupId': 'OG000'}, {'value': '144.9', 'spread': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose', 'description': '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '651.4', 'spread': '50', 'groupId': 'OG000'}, {'value': '3382', 'spread': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '681.8', 'spread': '51', 'groupId': 'OG000'}, {'value': '3475', 'spread': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose', 'description': '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.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who enrolled and treated with at least 1 concentration measurement of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Number of Participants with all-causality TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants with all-causality SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants with treatment-related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of Participants with treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Mild (all causalities)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate (all causalities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe (all causalities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mild (treatment-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate (treatment-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe (treatment-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Monocytes/Leukocytes (%) >1.2*ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urine Nitrite >=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urine Bacteria (/LPF) >20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pre-defined Criteria for Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'OG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'classes': [{'title': 'Supine DBP <50 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP change >= 20mmHg increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP change >= 20mmHg decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP change >=30mmHg increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP change >=30mmHg decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine pulse rate <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Supine pulse rate >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study treatment and who were evaluated against criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'FG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RITLECITINIB 50 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 50 mg single dose of ritlecitinib capsule on Day 1.'}, {'id': 'BG001', 'title': 'RITLECITINIB 200 MG CAPSULE', 'description': 'Healthy participants enrolled to receive 200 mg single dose of 4 ritlecitinib 50 mg capsules on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '10.95', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '12.97', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-44', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '45-64', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all enrolled participants who received at least one dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-10', 'size': 3592642, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-15T15:59', 'hasProtocol': True}, {'date': '2021-10-18', 'size': 2475817, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-15T15:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2021-10-15', 'resultsFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-09', 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Target Occupancy for JAK3', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.'}, {'measure': 'Percent Target Occupancy for BTK', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': "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."}, {'measure': 'Percent Target Occupancy for ITK', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.'}, {'measure': 'Percent Target Occupancy for TXK', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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': 'Percent Target Occupancy for TEC', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.'}, {'measure': 'Percent Target Occupancy for BMX', 'timeFrame': '-1 (pre-dose), 0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Cmax is maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Tmax is time for Cmax. Tmax for ritlecitinib was observed directly from data as time of first occurrence.'}, {'measure': 'Last Quantifiable Plasma Concentration (Clast) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': 'Clast is last quantifiable plasma concentration. Clast for ritlecitinib was observed directly from data.'}, {'measure': 'Average Plasma Concentration From Time 0 to 24 Hours (Cav) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose', 'description': '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.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24, 48 hours post-dose', 'description': '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.'}, {'measure': 'Area Under the Curve From Time 0 to 24 Hours (AUC24) of Ritlecitinib', 'timeFrame': '0 (pre-dose), 1, 2, 4, 8, 24 hours post-dose', 'description': '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.'}, {'measure': 'Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events by Severity', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': "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."}, {'measure': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.'}, {'measure': 'Number of Participants With Pre-defined Criteria for Vital Signs', 'timeFrame': 'From the first dose of study treatment up to 35 days after the last dose of study treatment (up to 35 days)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38267790', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7981045', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination including BP and pulse rate measurement, 12-lead ECG, or clinical and laboratory tests.\n* BMI of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lb).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n* Infection with HIV, hepatitis B or hepatitis C viruses\n* Have evidence of untreated or inadequately treated active or latent Mycobacterium TB infection\n* Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.\n* Have received only one of the 2 required doses of COVID-19 vaccine.\n* Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.'}, 'identificationModule': {'nctId': 'NCT05128058', 'briefTitle': 'A Target Occupancy Study With Ritlecitinib.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN LABEL, PHASE 1, TWO-ARM STUDY TO ASSESS TARGET OCCUPANCY AND FUNCTIONAL INHIBITION OF JAK3 AND TEC KINASES BY SINGLE DOSES OF RITLECITINIB IN HEALTHY ADULT PARTICIPANTS', 'orgStudyIdInfo': {'id': 'B7981045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Subjects will be dosed with 50 mg Ritlecitinib on Day 1 and followed up till Day 3', 'interventionNames': ['Drug: Ritlecitinib 50 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Subjects will be dosed with 200 mg Ritlecitinib on Day 1 and followed up till Day 3', 'interventionNames': ['Drug: Ritlecitinib 200 mg']}], 'interventions': [{'name': 'Ritlecitinib 50 mg', 'type': 'DRUG', 'otherNames': ['PF-06651600'], 'description': '50 mg single dose', 'armGroupLabels': ['Cohort 1']}, {'name': 'Ritlecitinib 200 mg', 'type': 'DRUG', 'otherNames': ['PF-06651600'], 'description': '200 mg single dose', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Clinical Research Unit - New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}