Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT06393127
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2024-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000727475', 'term': 'BI 1015550'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events: from drug administration up to 7 days. All-cause mortality: from drug administration until end of study examination, up to 37 days.', 'description': 'Treated set (TS): includes all subjects who were treated with at least one dose of trial drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Reference treatment (R)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 5, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test treatment (T)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test treatment (T)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'OG001', 'title': 'Reference treatment (R)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}], 'classes': [{'categories': [{'measurements': [{'value': '2275.77', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.04', 'groupId': 'OG000'}, {'value': '2166.70', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.03', 'ciLowerLimit': '99.07', 'ciUpperLimit': '111.36', 'estimateComment': 'Ratio \\[%\\] = (adjusted geometric mean of T / adjusted geometric mean R)\\*100. Intra-individual geometric coefficient of variation (gCV) \\[%\\] = 18.8', 'groupDescription': 'Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Area under the concentration-time curve of nerandomilast (R-BI 1015550) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'unitOfMeasure': 'hour*nanomole/Liter (h*nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): includes all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if they contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available PK data are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test treatment (T)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'OG001', 'title': 'Reference treatment (R)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}], 'classes': [{'categories': [{'measurements': [{'value': '417.47', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.05', 'groupId': 'OG000'}, {'value': '368.38', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '113.32', 'ciLowerLimit': '102.70', 'ciUpperLimit': '125.05', 'estimateComment': 'Ratio \\[%\\] = (adjusted geometric mean of T / adjusted geometric mean R)\\*100. Intra-individual geometric coefficient of variation (gCV) \\[%\\] = 32.8', 'groupDescription': 'Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Maximum measured concentration of nerandomilast (R-BI 1015550) in plasma (Cmax) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'unitOfMeasure': 'nanomole/Liter (nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): includes all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if they contributed only 1 PK parameter value for 1 period to the statistical assessment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test treatment (T)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'OG001', 'title': 'Reference treatment (R)', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}], 'classes': [{'categories': [{'measurements': [{'value': '2298.06', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.04', 'groupId': 'OG000'}, {'value': '2189.77', 'spread': 'NA', 'comment': 'Adjusted geometric standard error = 1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means [%]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.95', 'ciLowerLimit': '99.10', 'ciUpperLimit': '111.14', 'estimateComment': 'Ratio \\[%\\] = (adjusted geometric mean of T / adjusted geometric mean R)\\*100. Intra-individual geometric coefficient of variation (gCV) \\[%\\] = 18.5', 'groupDescription': 'Ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Area under the concentration-time curve of nerandomilast (R-BI 1015550) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.', 'unitOfMeasure': 'hour*nanomole/Liter (h*nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set (PKS): includes all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if they contributed only 1 PK parameter value for 1 period to the statistical assessment. Only participants with available PK data are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test treatment (T), then reference treatment (R): T-R', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R).\n\nBoth treatments were administered orally with approximately 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'FG001', 'title': 'Reference treatment (R), then test treatment (T): R-T', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T).\n\nBoth treatments were administered orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}], 'periods': [{'title': 'Treatment period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One subject received the wrong treatment.', 'groupId': 'FG000', 'numSubjects': '32'}, {'comment': 'Three subjects received the wrong treatment.', 'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance from subject with trial procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a open-label, randomised, single-dose, two-way crossover trial in healthy subjects to compare the test treatment (T - nerandomilast \\[BI 1015550\\] Formulation C2) to the reference treatment (R - nerandomilast Formulation C1, as the phase 3 formulation). Subjects were randomly allocated to the 2 treatment sequences (T-R or R-T), and there was a washout period of at least 10 days between the administration of each treatment.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Screening procedures also included physical examination, check of vital signs, electrocardiogram, safety laboratory, demographics, relevant medical history, concomitant therapy. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Treatment (T), Then Reference Treatment (R): T-R', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R).\n\nBoth treatments were administered orally with approximately 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'BG001', 'title': 'Reference Treatment (R), Then Test Treatment (T): R-T', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T).\n\nBoth treatments were administered orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): includes all subjects who were treated with at least one dose of trial drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-15', 'size': 654794, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-30T12:09', 'hasProtocol': True}, {'date': '2024-09-12', 'size': 289705, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-30T12:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-04-29', 'resultsFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-14', 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Area under the concentration-time curve of nerandomilast (R-BI 1015550) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.'}, {'measure': 'Maximum Measured Concentration of Nerandomilast in Plasma (Cmax)', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Maximum measured concentration of nerandomilast (R-BI 1015550) in plasma (Cmax) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)', 'timeFrame': 'Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration.', 'description': 'Area under the concentration-time curve of nerandomilast (R-BI 1015550) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\n\nGeometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: "subjects within sequences" as random effect, "sequence", "period" and "treatment" as fixed effects. These quantities were then back-transformed to the original scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy male or female subject according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests\n2. Age of 18 to 50 years (inclusive)\n3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)\n4. Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening\n4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT06393127', 'briefTitle': 'A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of the BI 1015550 High Dose Formulation C2 and the BI 1015550 High Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)', 'orgStudyIdInfo': {'id': '1305-0037'}, 'secondaryIdInfos': [{'id': '2023-509950-67-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1301-0834', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test treatment (T), then reference treatment (R): T-R', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R).\n\nBoth treatments were administered orally with approximately 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After drug administration, subjects additionally fasted for 4 h.', 'interventionNames': ['Drug: Nerandomilast']}, {'type': 'EXPERIMENTAL', 'label': 'Reference treatment (R), then test treatment (T): R-T', 'description': 'Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T).\n\nBoth treatments were administered orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.', 'interventionNames': ['Drug: Nerandomilast']}], 'interventions': [{'name': 'Nerandomilast', 'type': 'DRUG', 'otherNames': ['BI 1015550', 'JASCAYD®'], 'description': 'One dose of Formulation C2 (Test treatment - T) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.', 'armGroupLabels': ['Reference treatment (R), then test treatment (T): R-T', 'Test treatment (T), then reference treatment (R): T-R']}, {'name': 'Nerandomilast', 'type': 'DRUG', 'otherNames': ['BI 1015550', 'JASCAYD®'], 'description': 'One dose of Formulation C1 - phase 3 formulation (Reference treatment - R) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.', 'armGroupLabels': ['Reference treatment (R), then test treatment (T): R-T', 'Test treatment (T), then reference treatment (R): T-R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}