Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:40 PM
Study NCT ID:
NCT04756960
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596339', 'term': 'tanimilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials_info@chiesi.com', 'phone': '+ 39 0521 2791', 'title': 'Clinical Trial Transparency', 'organization': 'Chiesi Farmaceutici S.p.A.'}, 'certainAgreement': {'otherDetails': 'Investigator should inform Chiesi Farmaceutici S.p.A. before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were monitored from the time of the Informed Consent signature (screening visit at 31 to 3 days before the study treatment administration) until the subject's study participation ended (follow-up phone call or visit at 7 to 10 days after discharge or premature discontinuation).", 'eventGroups': [{'id': 'EG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4025', 'spread': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'AUC(0-t\\_iv) for \\[14\\^C\\] total in plasma.\n\nAUC(0-t\\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration.', 'unitOfMeasure': 'h*ngEq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- C(max_iv) -- Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7072', 'spread': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'C(max\\_iv) for \\[14\\^C\\] total in plasma.\n\nC(max\\_iv)=Peak plasma concentration after intravenous (iv) infusion administration', 'unitOfMeasure': 'ngEq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(max_iv) -- Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.217', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 't(max\\_iv) for \\[14\\^C\\] total.\n\nt(max\\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0825', 'spread': '19.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Area under curve extrapolated to infinity (AUC(0-∞\\_iv) for \\[14\\^C\\] total in plasma.\n\nAUC(0-∞\\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h*ngEq/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4057', 'groupId': 'OG000', 'lowerLimit': '56.446', 'upperLimit': '105.776'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Terminal half-life t(1/2\\_iv) for \\[14\\^C\\] total and CHF6001.\n\nt1/2\\_iv=Terminal half-life, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- (Blood to Plasma Ratio) -- Blood, Plasma -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6490', 'spread': '23.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.', 'description': 'Blood to plasma ratio for \\[14\\^C\\] total.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7825', 'spread': '18.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'AUC(0-t\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nAUC(0-t\\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- C(max_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6312', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'C(max\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nC(max\\_iv)=Peak plasma concentration, after intravenous (iv) infusion administration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(max_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.217', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 't(max\\_iv) for \\[14\\^C\\] CHF6001.\n\nt(max\\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8138', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Area under curve extrapolated to infinity (AUC0-∞\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nAUC(0-∞\\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5816', 'groupId': 'OG000', 'lowerLimit': '6.452', 'upperLimit': '33.092'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Terminal half-life t(1/2\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nt(1/2\\_iv)=Terminal half-life, after intravenous (iv) infusion administration', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Volume of Distribution During the Terminal Phase (Vz_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '436.1078', 'spread': '38.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Volume of distribution during the terminal phase (Vz\\_iv) of \\[14\\^C\\] CHF6001 in plasma.\n\nVz\\_iv=Volume of distribution during the terminal phase, after intravenous (iv) infusion administration', 'unitOfMeasure': 'Litres', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Vdss_iv -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14\\^C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14\\^C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '201.2514', 'spread': '36.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Vdss\\_iv=Volume of distribution is calculated at steady-state for \\[14\\^C\\] CHF6001 in plasma, after intravenous (iv) infusion administration.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Clearance (CL_iv) -- Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001.\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9951', 'spread': '18.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Systemic plasma clearance for \\[14\\^C\\] CHF6001.', 'unitOfMeasure': 'Litres/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Blood to Plasma Ratio -- Blood, Plasma -- [14^C] CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5166', 'spread': '54.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.', 'description': 'Blood to plasma ratio for \\[14\\^C\\] CHF6001.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-t)_inh -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '71088', 'spread': '28.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'AUC(0-t)\\_inh for CHF6001 in plasma.\n\nAUC(0-t)\\_inh=Area Under the curve, from 0 to the last quantifiable concentration after inhalation of CHF6001', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- C(max_inh) -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '1979', 'spread': '22.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 'C(max\\_inh) for CHF6001 in plasma.\n\nC(max\\_inh)=Peak plasma concentration after inhalation of CHF6001', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(max_inh) -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '2.008', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '3.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 't(max\\_inh) for CHF6001 in plasma.\n\nt(max\\_inh)=Time to reach the Cmax after inhalation of CHF6001', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- AUC(0-∞_inh) -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '72403', 'spread': '28.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'AUC(0-∞\\_inh) for CHF6001 in plasma.\n\nAUC(0-∞\\_inh)=Area under curve extrapolated to infinity after inhalation of CHF6001', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- t(1/2_inh) -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5691', 'groupId': 'OG000', 'lowerLimit': '25.930', 'upperLimit': '45.159'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 't(1/2\\_inh) for CHF6001 in plasma.\n\nt(1/2\\_inh)=Terminal half-life, after inhalation of CHF6001', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Absolute Inhaled Bioavailability (F_inh) -- Plasma -- CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4977', 'spread': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'Absolute inhaled bioavailability for CHF6001.\n\nF\\_inh=Inhaled absolute bioavailability based on AUC(0-∞) after inhalation of CHF6001 F\\_inh=(AUC(0-∞)\\_inh x Dose\\_iv)/ (AUC(0-∞)\\_iv x Dose\\_inh).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-4 h', 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.523', 'groupId': 'OG000'}]}]}, {'title': '4-8 h', 'categories': [{'measurements': [{'value': '3.26', 'spread': '0.552', 'groupId': 'OG000'}]}]}, {'title': '8-12 h', 'categories': [{'measurements': [{'value': '3.93', 'spread': '0.549', 'groupId': 'OG000'}]}]}, {'title': '12-24 h', 'categories': [{'measurements': [{'value': '5.24', 'spread': '0.554', 'groupId': 'OG000'}]}]}, {'title': '24-48 h', 'categories': [{'measurements': [{'value': '6.77', 'spread': '0.519', 'groupId': 'OG000'}]}]}, {'title': '48-72 h', 'categories': [{'measurements': [{'value': '7.35', 'spread': '0.553', 'groupId': 'OG000'}]}]}, {'title': '72-96 h', 'categories': [{'measurements': [{'value': '7.64', 'spread': '0.622', 'groupId': 'OG000'}]}]}, {'title': '96-120 h', 'categories': [{'measurements': [{'value': '7.80', 'spread': '0.673', 'groupId': 'OG000'}]}]}, {'title': '120-144 h', 'categories': [{'measurements': [{'value': '7.89', 'spread': '0.703', 'groupId': 'OG000'}]}]}, {'title': '144-168 h', 'categories': [{'measurements': [{'value': '7.96', 'spread': '0.720', 'groupId': 'OG000'}]}]}, {'title': '168-192 h', 'categories': [{'measurements': [{'value': '8.01', 'spread': '0.729', 'groupId': 'OG000'}]}]}, {'title': '192-216 h', 'categories': [{'measurements': [{'value': '8.06', 'spread': '0.763', 'groupId': 'OG000'}]}]}, {'title': '216-240 h', 'categories': [{'measurements': [{'value': '8.10', 'spread': '0.771', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.', 'description': 'Urine excreted fraction for cumulative \\[14\\^C\\] total.', 'unitOfMeasure': 'Cumulative % of dose excreted in urine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-4 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-8 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-12 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-24 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-48 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-72 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-96 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-120 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-144 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-168 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-192 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-216 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '0-240 h', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.', 'description': 'Urine excreted fraction for cumulative \\[14\\^C\\]-CHF6001.\n\nMeasurements in urine were performed. All measured values were below the limit of quantification of the bioanalytical method.', 'unitOfMeasure': '(%) percent of injected [14C]-CHF6001', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.\n\nMeasurements in urine were performed and no substance was detected.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-24 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.64', 'spread': '12.0', 'groupId': 'OG000'}]}]}, {'title': '24-48 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.9', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': '48-72 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '8.53', 'groupId': 'OG000'}]}]}, {'title': '72-96 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.9', 'spread': '4.26', 'groupId': 'OG000'}]}]}, {'title': '96-120 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '2.35', 'groupId': 'OG000'}]}]}, {'title': '120-144 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.6', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': '144-168 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': '168-192 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.5', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': '192-216 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '2.22', 'groupId': 'OG000'}]}]}, {'title': '216-240 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.8', 'spread': '2.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.', 'description': 'Fecal excreted fraction for cumulative \\[14\\^C\\] total.', 'unitOfMeasure': 'Cumulative % of dose excreted in feces', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-24 h', 'categories': [{'measurements': [{'value': '0.0435', 'spread': '0.0676', 'groupId': 'OG000'}]}]}, {'title': '0-48 h', 'categories': [{'measurements': [{'value': '0.1748', 'spread': '0.0895', 'groupId': 'OG000'}]}]}, {'title': '0-72 h', 'categories': [{'measurements': [{'value': '0.2507', 'spread': '0.0855', 'groupId': 'OG000'}]}]}, {'title': '0-96 h', 'categories': [{'measurements': [{'value': '0.2816', 'spread': '0.0685', 'groupId': 'OG000'}]}]}, {'title': '0-120 h', 'categories': [{'measurements': [{'value': '0.3048', 'spread': '0.0660', 'groupId': 'OG000'}]}]}, {'title': '0-144 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-168 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-192 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-216 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-240 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.', 'description': 'Fecal excreted fraction for cumulative \\[14\\^C\\]-CHF6001.', 'unitOfMeasure': '(%) percent of injected [14C]-CHF6001', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-4 h', 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.523', 'groupId': 'OG000'}]}]}, {'title': '4-8 h', 'categories': [{'measurements': [{'value': '3.26', 'spread': '0.552', 'groupId': 'OG000'}]}]}, {'title': '8-12 h', 'categories': [{'measurements': [{'value': '3.93', 'spread': '0.549', 'groupId': 'OG000'}]}]}, {'title': '12-24 h', 'categories': [{'measurements': [{'value': '12.9', 'spread': '12.3', 'groupId': 'OG000'}]}]}, {'title': '24-48 h', 'categories': [{'measurements': [{'value': '45.6', 'spread': '20.8', 'groupId': 'OG000'}]}]}, {'title': '48-72 h', 'categories': [{'measurements': [{'value': '65.1', 'spread': '8.67', 'groupId': 'OG000'}]}]}, {'title': '72-96 h', 'categories': [{'measurements': [{'value': '72.5', 'spread': '4.12', 'groupId': 'OG000'}]}]}, {'title': '96-120 h', 'categories': [{'measurements': [{'value': '76.4', 'spread': '2.46', 'groupId': 'OG000'}]}]}, {'title': '120-144 h', 'categories': [{'measurements': [{'value': '77.5', 'spread': '2.23', 'groupId': 'OG000'}]}]}, {'title': '144-168 h', 'categories': [{'measurements': [{'value': '77.9', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': '168-192 h', 'categories': [{'measurements': [{'value': '78.5', 'spread': '2.46', 'groupId': 'OG000'}]}]}, {'title': '192-216 h', 'categories': [{'measurements': [{'value': '78.7', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': '216-240 h', 'categories': [{'measurements': [{'value': '78.9', 'spread': '2.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).', 'description': 'Urine and fecal excreted fraction for cumulative \\[14\\^C\\] total.', 'unitOfMeasure': 'Cumulative % of dose excreted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}, {'type': 'PRIMARY', 'title': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14C\\]-labelled CHF6001'}], 'classes': [{'title': '0-24 h', 'categories': [{'measurements': [{'value': '0.0435', 'spread': '0.0676', 'groupId': 'OG000'}]}]}, {'title': '0-48 h', 'categories': [{'measurements': [{'value': '0.1748', 'spread': '0.0895', 'groupId': 'OG000'}]}]}, {'title': '0-72 h', 'categories': [{'measurements': [{'value': '0.2507', 'spread': '0.0855', 'groupId': 'OG000'}]}]}, {'title': '0-96 h', 'categories': [{'measurements': [{'value': '0.2816', 'spread': '0.0685', 'groupId': 'OG000'}]}]}, {'title': '0-120 h', 'categories': [{'measurements': [{'value': '0.3048', 'spread': '0.0660', 'groupId': 'OG000'}]}]}, {'title': '0-144 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-168 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-192 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-216 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}, {'title': '0-240 h', 'categories': [{'measurements': [{'value': '0.3060', 'spread': '0.0642', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).', 'description': 'Urine and Fecal excreted fraction for cumulative \\[14\\^C\\]-CHF6001.', 'unitOfMeasure': '(%) percent of injected [14C]-CHF6001', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population: all subjects from the safety population excluding subjects without any valid pharmacokinetic (PK) measurement or with major protocol deviations significantly affecting PK, for example: incorrect inhalation, change in subject condition (cold), failure in delivery of the device, use of non-permitted medications.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 dry-powder inhaler (DPI) co-administered with an intravenous microdose of \\[14\\^C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14\\^C\\]-labelled CHF6001'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CHF6001', 'description': 'Single dose of CHF6001 DPI co-administered with an intravenous microdose of \\[14\\^C\\]-labelled CHF6001\n\nCHF6001: 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of \\[14\\^C\\]-labelled CHF6001'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.09', 'spread': '4.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Healthy male subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-19', 'size': 623730, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-22T12:00', 'hasProtocol': True}, {'date': '2022-03-15', 'size': 638768, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-22T12:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2021-02-08', 'resultsFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-04', 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'AUC(0-t\\_iv) for \\[14\\^C\\] total in plasma.\n\nAUC(0-t\\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration.'}, {'measure': 'PK Parameter -- C(max_iv) -- Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'C(max\\_iv) for \\[14\\^C\\] total in plasma.\n\nC(max\\_iv)=Peak plasma concentration after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- t(max_iv) -- Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 't(max\\_iv) for \\[14\\^C\\] total.\n\nt(max\\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Area under curve extrapolated to infinity (AUC(0-∞\\_iv) for \\[14\\^C\\] total in plasma.\n\nAUC(0-∞\\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Terminal half-life t(1/2\\_iv) for \\[14\\^C\\] total and CHF6001.\n\nt1/2\\_iv=Terminal half-life, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- (Blood to Plasma Ratio) -- Blood, Plasma -- [14^C] Total', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.', 'description': 'Blood to plasma ratio for \\[14\\^C\\] total.'}, {'measure': 'PK Parameter -- AUC(0-t_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'AUC(0-t\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nAUC(0-t\\_iv)=Area Under the curve, from 0 to the last quantifiable concentration, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- C(max_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'C(max\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nC(max\\_iv)=Peak plasma concentration, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- t(max_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 't(max\\_iv) for \\[14\\^C\\] CHF6001.\n\nt(max\\_iv)=Time to reach the Cmax, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- AUC(0-∞_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Area under curve extrapolated to infinity (AUC0-∞\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nAUC(0-∞\\_iv)=Area under curve extrapolated to infinity, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- t(1/2_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Terminal half-life t(1/2\\_iv) for \\[14\\^C\\] CHF6001 in plasma.\n\nt(1/2\\_iv)=Terminal half-life, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- Volume of Distribution During the Terminal Phase (Vz_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Volume of distribution during the terminal phase (Vz\\_iv) of \\[14\\^C\\] CHF6001 in plasma.\n\nVz\\_iv=Volume of distribution during the terminal phase, after intravenous (iv) infusion administration'}, {'measure': 'PK Parameter -- Vdss_iv -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Vdss\\_iv=Volume of distribution is calculated at steady-state for \\[14\\^C\\] CHF6001 in plasma, after intravenous (iv) infusion administration.'}, {'measure': 'PK Parameter -- Clearance (CL_iv) -- Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints relative to the start of the IV infusion: 5, 10, 15 [end of infusion], 20, 25, 30, 45, 60 min, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours.', 'description': 'Systemic plasma clearance for \\[14\\^C\\] CHF6001.'}, {'measure': 'PK Parameter -- Blood to Plasma Ratio -- Blood, Plasma -- [14^C] CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at 20 min after the start of IV infusion.', 'description': 'Blood to plasma ratio for \\[14\\^C\\] CHF6001.'}, {'measure': 'PK Parameter -- AUC(0-t)_inh -- Plasma -- CHF6001', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'AUC(0-t)\\_inh for CHF6001 in plasma.\n\nAUC(0-t)\\_inh=Area Under the curve, from 0 to the last quantifiable concentration after inhalation of CHF6001'}, {'measure': 'PK Parameter -- C(max_inh) -- Plasma -- CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 'C(max\\_inh) for CHF6001 in plasma.\n\nC(max\\_inh)=Peak plasma concentration after inhalation of CHF6001'}, {'measure': 'PK Parameter -- t(max_inh) -- Plasma -- CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 't(max\\_inh) for CHF6001 in plasma.\n\nt(max\\_inh)=Time to reach the Cmax after inhalation of CHF6001'}, {'measure': 'PK Parameter -- AUC(0-∞_inh) -- Plasma -- CHF6001', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'AUC(0-∞\\_inh) for CHF6001 in plasma.\n\nAUC(0-∞\\_inh)=Area under curve extrapolated to infinity after inhalation of CHF6001'}, {'measure': 'PK Parameter -- t(1/2_inh) -- Plasma -- CHF6001', 'timeFrame': 'Pre-dose (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours.', 'description': 't(1/2\\_inh) for CHF6001 in plasma.\n\nt(1/2\\_inh)=Terminal half-life, after inhalation of CHF6001'}, {'measure': 'PK Parameter -- Absolute Inhaled Bioavailability (F_inh) -- Plasma -- CHF6001', 'timeFrame': 'At baseline (pre-dose) (within 60 min from inhaled dosing) and at the following timepoints post inhaled dose: 15, 30, 60, 90 min, 2, 3.75, 5.75, 7.75, 9.75, 11.75, 13.75, 25.75, 49.75, 73.75, 97.75, 121.75, 145.75, 169.75, 193.75, 217.75, and 241.75 hours', 'description': 'Absolute inhaled bioavailability for CHF6001.\n\nF\\_inh=Inhaled absolute bioavailability based on AUC(0-∞) after inhalation of CHF6001 F\\_inh=(AUC(0-∞)\\_inh x Dose\\_iv)/ (AUC(0-∞)\\_iv x Dose\\_inh).'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C] Total', 'timeFrame': 'Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.', 'description': 'Urine excreted fraction for cumulative \\[14\\^C\\] total.'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine -- [14^C]-CHF6001', 'timeFrame': 'Baseline (pre dose, -12-0h) and relative to the start of the IV infusion at: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216-240h.', 'description': 'Urine excreted fraction for cumulative \\[14\\^C\\]-CHF6001.\n\nMeasurements in urine were performed. All measured values were below the limit of quantification of the bioanalytical method.'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C] Total', 'timeFrame': 'Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.', 'description': 'Fecal excreted fraction for cumulative \\[14\\^C\\] total.'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Fecal -- [14^C]-CHF6001', 'timeFrame': 'Baseline (pre dose, Day -1) and relative to the start of the IV infusion at: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h, 168-192h, 192-216h, and 216 -240h.', 'description': 'Fecal excreted fraction for cumulative \\[14\\^C\\]-CHF6001.'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C] Total', 'timeFrame': 'Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).', 'description': 'Urine and fecal excreted fraction for cumulative \\[14\\^C\\] total.'}, {'measure': 'PK Parameter -- Cumulative Excreted Fraction (in %) -- Urine and Fecal -- [14^C]-CHF6001', 'timeFrame': 'Over 240 h after administration; please see timepoints for outcome #22 (urine) and #24 (fecal).', 'description': 'Urine and Fecal excreted fraction for cumulative \\[14\\^C\\]-CHF6001.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Healthy subjects', 'Phase I', 'CHF6001', 'Tanimilast', 'Chiesi Farmaceutici S.p.A'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)', 'COPD']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male subjects.', 'detailedDescription': 'This clinical trial is a single centre Phase I study, with a single dose, non-randomized, open-label, uncontrolled design. A total of 8 healthy male subjects were included in the study.\n\nThe aim was to assess the absolute bioavailability, the mass balance, and routes of elimination of CHF6001 (Tanimilast) in healthy male subjects, using \\[14\\^C\\]-radiolabelled drug substance, administered as an intravenous (iv) infusion concomitantly with an inhaled (inh) non-radiolabelled dose of CHF6001.\n\nStandard safety assessments were conducted during the study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs, and assessment of any adverse events (AE). Blood, urine, and feces samples were collected for pharmacokinetic (PK) analyses.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject's written informed consent obtained prior to any study-related procedure;\n2. Able to understand the study procedures, the risks involved and ability to be trained to use correctly the inhalers and to generate sufficient Peak Inspiratory Flow (PIF), using the In-Check device and Placebo inhaler;\n3. Male subjects aged 30 to 55 years inclusive;\n4. Body mass index (BMI) within the range of 18 to 35 kg/m\\^2 inclusive;\n5. Non- or ex-smoker who smoked \\< 5 pack years and who stopped smoking \\> 1 year prior to screening;\n6. Good physical and mental status;\n7. Vital signs at screening within limits;\n8. 12-lead digitised Electrocardiogram (12-lead ECG) in triplicate considered as normal;\n9. Lung function measurements within normal limits at screening;\n10. Regular bowel movements at screening;\n11. Males with non-pregnant Women of Childbearing Potential (WOCBP) partners: they and/or their partner of childbearing potential must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until 90 days after the follow-up visit. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until 90 days after the follow-up visit.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial with an investigational drug in the 3 months or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug;\n2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic (including Gilbert syndrome), gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorder;\n3. Clinically relevant abnormal laboratory values;\n4. Subjects with history of breathing problems;\n5. Positive to Human Immunodeficiency Virus 1/Human Immunodeficiency Virus 2 (HIV1/HIV2) serology at screening;\n6. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening;\n7. Blood donation or blood loss (equal or more than 450 mL) less than 2 months prior screening or prior to treatment;\n8. Positive urine test for cotinine;\n9. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test;\n10. Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen;\n11. Intake of non-permitted concomitant medications in the predefined period;\n12. Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before treatment;\n13. Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;\n14. Unsuitable veins for repeated venipuncture;\n15. Heavy caffeine drinker;\n16. Abnormal haemoglobin level at screening;\n17. Subjects using e-cigarettes within 6 months prior to screening;\n18. Subjects been involved in a study involving a 14\\^C-labeled drug within the 12 months prior to enrollment;\n19. Subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day-1;\n20. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or which has not resolved within 14 days prior to screening and before treatment."}, 'identificationModule': {'nctId': 'NCT04756960', 'briefTitle': 'Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 Following a Single Inhaled Dose Co-administered With an Intravenous Radiolabelled Microtracer Dose in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CLI-06001AA1-02'}, 'secondaryIdInfos': [{'id': '2020-004201-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF6001', 'description': 'single dose of CHF6001 dry-powder inhaler (DPI) co-administered with an intravenous microdose of \\[14\\^C\\]-labelled CHF6001', 'interventionNames': ['Drug: CHF6001']}], 'interventions': [{'name': 'CHF6001', 'type': 'DRUG', 'description': '4 inhalations of CHF6001 800 µg/20 mg NEXThaler® dry-powder inhaler (DPI), (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5 kBq)) of \\[14\\^C\\]-labelled CHF6001', 'armGroupLabels': ['CHF6001']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance - Clinical Research Unit', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}