Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-09 @ 4:15 AM
Study NCT ID:
NCT05627518
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
Sponsor:
Organization:
Raw JSON
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Ratio of Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reference Formulation (Treatment A)', 'description': '4 x 25 mg linaprazan glurate reference formulation, fasting conditions'}, {'id': 'OG001', 'title': 'Test Formulation (Treatment B)', 'description': '100 mg linaprazan glurate test formulation, fasting conditions\n\nLinaprazan glurate: 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '86.8', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '214.3', 'spread': '2.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0245', 'ciLowerLimit': '2.5098', 'ciUpperLimit': '3.6446', 'estimateComment': 'Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)', 'groupDescription': 'Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax (highest measured concentration) of linaprazan glurate comparing the test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf, AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Formulation (Treatment B)', 'description': '100 mg linaprazan glurate test formulation, fasting conditions\n\nLinaprazan glurate: 100 mg'}, {'id': 'OG001', 'title': 'Test Formulation (Treatment C)', 'description': '100 mg linaprazan glurate test formulation, fed conditions\n\nLinaprazan glurate: 100 mg'}], 'classes': [{'title': 'AUCinf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '320.2', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '166.3', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'AUClast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '293.0', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '144.3', 'spread': '1.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4923', 'ciLowerLimit': '0.4131', 'ciUpperLimit': '0.5867', 'estimateComment': 'Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)', 'groupDescription': 'Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4923', 'ciLowerLimit': '0.4047', 'ciUpperLimit': '0.5989', 'estimateComment': 'Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)', 'groupDescription': 'Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan glurate, comparing test formulation vs reference formulation (treatments C vs treatment B) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased in a fed vs fasted state.', 'unitOfMeasure': 'hours * nmol/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratio of Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Formulation (Treatment B)', 'description': '100 mg linaprazan glurate test formulation, fasting conditions\n\nLinaprazan glurate: 100 mg'}, {'id': 'OG001', 'title': 'Test Formulation (Treatment C)', 'description': '100 mg linaprazan glurate test formulation, fed conditions\n\nLinaprazan glurate: 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '214.3', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '2.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2522', 'ciLowerLimit': '0.1980', 'ciUpperLimit': '0.3211', 'estimateComment': 'Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)', 'groupDescription': 'Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Ratio'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax of linaprazan glurate when comparing test formulation vs reference formulation (treatments C vs treatment B), i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence A B C', 'description': 'Treatments A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted'}, {'id': 'FG001', 'title': 'Treatment Sequence A C B', 'description': 'Treatments A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted'}, {'id': 'FG002', 'title': 'Treatment Sequence B A C', 'description': 'Treatments B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted C = 100 mg test formulation (formulation B) fasted'}, {'id': 'FG003', 'title': 'Treatment Sequence B C A', 'description': 'Treatments B = 100 mg test formulation (formulation B) non-fasted C = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted'}, {'id': 'FG004', 'title': 'Treatment Sequence C A B', 'description': 'Treatments\n\nC = 100 mg test formulation (formulation B) fasted A = 100 mg reference formulation (formulation A) non-fasted B = 100 mg test formulation (formulation B) non-fasted'}, {'id': 'FG005', 'title': 'Treatment Sequence C B A', 'description': 'Treatment C = 100 mg test formulation (formulation B) fasted B = 100 mg test formulation (formulation B) non-fasted A = 100 mg reference formulation (formulation A) non-fasted'}, {'id': 'FG006', 'title': 'Exploratory Arm A B C', 'description': 'Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.'}, {'id': 'FG007', 'title': 'Exploratory Arm A C B', 'description': 'Subjects underdosed when receiving treatment A, receiving only 1x25 mg LG instead of 4x25. Subjects were excluded from the PK analysis set and their data are instead presented here as exploratory. Treatment sequence as in the title.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'comment': '13 subjects were underdosed in treatment period A, receiving 1x25 mg LG instead of 4x25 mg. These 13 subjects completed their remaining treatments but were excluded from the PK analysis set and were therefore given a separate "exploratory arm" when presented here.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'comment': 'Treatment period 2 means for example if a subject was randomized to treatment sequence C A B, he/she would receive treatment A in this treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'comment': 'Treatment period 3 means for example if a subject was randomized to treatment sequence C A B, he/she would receive treatment B in this treatment period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were recruited form CRS's database of healthy volunteers. All Volunteers were recruited in Slovenia, Ljubljana.", 'preAssignmentDetails': 'Approximately 84 healthy volunteers were planned to be screened to achieve 54 randomized subjects. 97 Volunteers were actually screened for eligibility, of those, 67 were Randomized and 49 Analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence A B C', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG001', 'title': 'Treatment A C B', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG002', 'title': 'Treatment B A C', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG003', 'title': 'Treatment B C A', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG004', 'title': 'Treatment C A B', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG005', 'title': 'Treatment C B A', 'description': 'Treatments A = 100 mg reference formulation non-fasted B = 100 mg test formualtion non-fasted C = 100 mg test formulation fasted'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '24.3', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '35'}, {'value': '26.4', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '45'}, {'value': '21.5', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '25'}, {'value': '29.6', 'groupId': 'BG004', 'lowerLimit': '19', 'upperLimit': '48'}, {'value': '22.3', 'groupId': 'BG005', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '24.1', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '48'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'In error, one subject recieved the treatments in reverse order from what he/she was randomized to. E.g. in the order B C A as opposed to randomized A C B.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Slovenia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '13 subjects were erroneously underdosed with 1x25 mg LG instead of 4x25 mg in the sequence arms starting with treatment A. These 13 subjects were excluded from the analysis set and replaced. Data was collected nevertheless and presented as "exploratory". This is why there is an imbalance between the number in the first two sequence arms.\n\nIn addition, in error, one subject recieved the treatments in reverse order from his/her randomization. E.g. B C A instead of as randomized to A C B.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-23', 'size': 10302845, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-17T05:36', 'hasProtocol': True}, {'date': '2023-01-16', 'size': 11141411, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-02T11:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2022-11-16', 'resultsFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-17', 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratios of AUCinf and AUClast', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.'}, {'measure': 'Relative Bioavailability of Linaprazan Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax (highest measured concentration) of linaprazan comparing the test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased with the new formulation.'}, {'measure': 'Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf and AUClast', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan, comparing test formulation vs reference formulation (treatments C vs treatment B) for Relative Bioavailability, i.e. how much linaprazan exposure is increased or decreased in a fed vs fasted state.'}, {'measure': 'Relative Bioavailability of Linaprazan Test Formulation in Fed vs. Fasting Conditions, Based on the Means Ratios for Cmax', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax of linaprazan when comparing test formulation vs reference formulation (treatments C vs treatment B), i.e. how much linaprazan exposure is increased or decreased with the new formulation.'}], 'secondaryOutcomes': [{'measure': 'Relative Bioavailability of Linaprazan Glurate for the Test Formulation vs. Reference Formulation of Linaprazan Glurate, Based on the Means Ratios of PK Parameters.', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprzan glurate, comparing test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.'}, {'measure': 'Relative Bioavailability of Linaprazan Glurate Comparing Test Formulation vs. Reference Formulation of Linaprazan Glurate. Ratio of Cmax', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax (highest measured concentration) of linaprazan glurate comparing the test formulation vs reference formulation (treatments B vs treatment A) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.'}, {'measure': 'Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratios for AUCinf, AUClast', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Area Under the plasma concentration vs. time Curve (AUC) from time 0 to infinity (AUCinf), and from time 0 to last measurement (AUClast) of linaprazan glurate, comparing test formulation vs reference formulation (treatments C vs treatment B) for Relative Bioavailability, i.e. how much linaprazan glurate exposure is increased or decreased in a fed vs fasted state.'}, {'measure': 'Relative Bioavailability of Linaprazan Glurate in Fed vs. Fasting Conditions, Based on the Means Ratio of Cmax', 'timeFrame': 'From pre-dose up to 72 h post dose', 'description': 'The Ratio of Cmax of linaprazan glurate when comparing test formulation vs reference formulation (treatments C vs treatment B), i.e. how much linaprazan glurate exposure is increased or decreased with the new formulation.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety', 'Bioavailability', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Willing and able to give written informed consent for participation in the study.\n2. Healthy male or female aged 18 to 65 years, inclusive.\n3. Body mass index ≥18.5 and ≤30.0 kg/m2.\n4. Medically healthy, without abnormal clinically significant medical history\n5. Female subjects of childbearing potential, as well as their partners and male subjects and their partners, who agree to using methods of contraception\n6. Willing and able to consume the high-fat, high calorie breakfast\n\nExclusion Criteria:\n\n1. Female subjects of childbearing potential unless they agree to use highly effective methods of contraception (failure rate of \\<1%) from 2 weeks prior to dosing until the end-of-study visit.\n2. Male subjects with a partner of childbearing potential, unless they agree to use method of contraception from 2 weeks prior to dosing until the end-of-study visit.History of or current clinically significant disease as defined in the protocol\n3. History of or current clinically significant disease as defined in the protocol.\n4. History of GERD, significant acid reflux.\n5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant (female subjects) or father a child (male subjects) during the course of the study (i.e., from screening to end of study visit).'}, 'identificationModule': {'nctId': 'NCT05627518', 'acronym': 'BA', 'briefTitle': 'Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cinclus Pharma Holding AB'}, 'officialTitle': 'A Randomized, Single Dose, Crossover Study in Healthy Volunteers to Investigate the Relative Bioavailability of Linaprazan for a New Oral Tablet Formulation of Linaprazan Glurate, and to Assess the Effect of Food on the Pharmacokinetics of Linaprazan', 'orgStudyIdInfo': {'id': 'CX842A2106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reference formulation (Treatment A)', 'description': '100 mg linaprazan glurate reference formulation (4x25 mg oral tablets) in fasting conditions', 'interventionNames': ['Drug: Linaprazan glurate']}, {'type': 'EXPERIMENTAL', 'label': 'Test formulation (Treatment B)', 'description': '100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fasting conditions', 'interventionNames': ['Drug: Linaprazan glurate']}, {'type': 'EXPERIMENTAL', 'label': 'Test Formulation (Treatment C)', 'description': '100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fed conditions', 'interventionNames': ['Drug: Linaprazan glurate']}], 'interventions': [{'name': 'Linaprazan glurate', 'type': 'DRUG', 'otherNames': ['formerly X842'], 'description': '100 mg', 'armGroupLabels': ['Reference formulation (Treatment A)', 'Test Formulation (Treatment C)', 'Test formulation (Treatment B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'state': 'Ukmarjeva Ulica 6', 'country': 'Slovenia', 'facility': 'CRS d.o.o.', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cinclus Pharma Holding AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}