Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 12:43 PM
Study NCT ID:
NCT04226833
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607349', 'term': 'entrectinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 4 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Entrectinib - Normal', 'description': 'Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Entrectinib Mild', 'description': 'Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Entrectinib Moderate', 'description': 'Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Entrectinib Severe', 'description': 'Participants received 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '296.140', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '213.570', 'spread': '36.7', 'groupId': 'OG001'}, {'value': '183.680', 'spread': '34.3', 'groupId': 'OG002'}, {'value': '235.990', 'spread': '46.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'title': 'Total Subjects With at Least 1 AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Subjects With at Least 1 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Total Subjects with at Least 1 Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'AE=adverse event TEAE=treatment-emergent adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5525.6', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '5401.9', 'spread': '49.1', 'groupId': 'OG001'}, {'value': '6329.0', 'spread': '58.5', 'groupId': 'OG002'}, {'value': '3512.7', 'spread': '50.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5263.9', 'spread': '48.4', 'groupId': 'OG000'}, {'value': '4952.3', 'spread': '49.0', 'groupId': 'OG001'}, {'value': '5747.9', 'spread': '53.6', 'groupId': 'OG002'}, {'value': '3283.2', 'spread': '51.5', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '4.83'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '2.95', 'upperLimit': '8.05'}, {'value': '3.000', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '5.97'}, {'value': '2.950', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Half-life (t1/2) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.75', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '30.43', 'spread': '36.5', 'groupId': 'OG001'}, {'value': '43.92', 'spread': '30.2', 'groupId': 'OG002'}, {'value': '21.34', 'spread': '36.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Rate Constant (Lz) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0229', 'spread': '0.00430', 'groupId': 'OG000'}, {'value': '0.0241', 'spread': '0.00858', 'groupId': 'OG001'}, {'value': '0.0165', 'spread': '0.00544', 'groupId': 'OG002'}, {'value': '0.0345', 'spread': '0.01359', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0200', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '0.0200', 'spread': '49.1', 'groupId': 'OG001'}, {'value': '43.92', 'spread': '30.2', 'groupId': 'OG002'}, {'value': '0.0300', 'spread': '50.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Obtained by dividing the total dose of parent drug by its corresponding AUCinf', 'unitOfMeasure': 'mg/(h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Apparent Volume of Distribution (Vz/F) of Entrectinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8000', 'spread': '47.7', 'groupId': 'OG000'}, {'value': '0.8100', 'spread': '37.6', 'groupId': 'OG001'}, {'value': '1.0000', 'spread': '35.2', 'groupId': 'OG002'}, {'value': '0.8800', 'spread': '43.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Obtained by dividing Dose by the product of AUCinf and λz', 'unitOfMeasure': 'mg/(nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.310', 'spread': '71.0', 'groupId': 'OG000'}, {'value': '26.390', 'spread': '68.6', 'groupId': 'OG001'}, {'value': '17.710', 'spread': '58.3', 'groupId': 'OG002'}, {'value': '60.330', 'spread': '41.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '2432.1', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '2024.3', 'spread': '58.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG002'}, {'value': '2229.9', 'spread': '40.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1255.2', 'spread': '67.8', 'groupId': 'OG000'}, {'value': '1297.3', 'spread': '52.4', 'groupId': 'OG001'}, {'value': '1202.8', 'spread': '62.9', 'groupId': 'OG002'}, {'value': '1715.6', 'spread': '48.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Maximum Observed Plasma Concentration (Tmax) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.83', 'upperLimit': '8.00'}, {'value': '5.955', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '35.50'}, {'value': '4.920', 'groupId': 'OG002', 'lowerLimit': '2.83', 'upperLimit': '71.80'}, {'value': '4.985', 'groupId': 'OG003', 'lowerLimit': '2.98', 'upperLimit': '7.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to Day 7', 'description': 'First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Rate Constant (Lz) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02000', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.0200', 'spread': '30.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG002'}, {'value': '0.0200', 'spread': '22.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Elimination Half-life (t1/2) of M5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'OG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.60', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '39.50', 'spread': '30.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG002'}, {'value': '38.33', 'spread': '22.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From Day 1 to Day 7', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'FG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'FG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'FG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants with reduced hepatic function were assigned to a functional category based on assessments at the Screening visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.'}, {'id': 'BG001', 'title': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'BG002', 'title': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'BG003', 'title': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '8.86', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '11.99', 'groupId': 'BG003'}, {'value': '57.3', 'spread': '9.88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-03', 'size': 701888, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-15T12:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2020-01-10', 'resultsFirstSubmitDate': '2022-09-26', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-15', 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7', 'description': 'First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units'}, {'measure': 'Apparent Terminal Elimination Half-life (t1/2) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Apparent Terminal Elimination Rate Constant (Lz) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Apparent Oral Clearance (CL/F) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Obtained by dividing the total dose of parent drug by its corresponding AUCinf'}, {'measure': 'The Apparent Volume of Distribution (Vz/F) of Entrectinib', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Obtained by dividing Dose by the product of AUCinf and λz'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of M5', 'timeFrame': 'From Day 1 to Day 7', 'description': 'Maximum observed plasma concentration. Observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of M5', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUClast) of M5', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of M5', 'timeFrame': 'From Day 1 to Day 7', 'description': 'First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units'}, {'measure': 'Apparent Terminal Elimination Rate Constant (Lz) of M5', 'timeFrame': 'From Day 1 to Day 7'}, {'measure': 'Apparent Terminal Elimination Half-life (t1/2) of M5', 'timeFrame': 'From Day 1 to Day 7'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '4 weeks', 'description': 'AE=adverse event TEAE=treatment-emergent adverse event'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Impairment'], 'conditions': ['Hepatic Insufficiency']}, 'referencesModule': {'references': [{'pmid': '39934586', 'type': 'DERIVED', 'citation': 'Ozbey AC, Meneses-Lorente G, Simmons B, McCallum S, Annaert P, Parrott N, Umehara K. Clinical Exploration and Physiologically Based Modelling of the Impact of Hepatic Impairment on Entrectinib Pharmacokinetics. Clin Pharmacokinet. 2025 Mar;64(3):437-451. doi: 10.1007/s40262-024-01468-y. Epub 2025 Feb 11.'}]}, 'descriptionModule': {'briefSummary': "This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic function. Participants with mild, moderate or severe hepatic impairment ('Mild', 'Moderate' and 'Severe' groups), and control participants with normal hepatic function ('Normal' group) will each receive a single 100 mg dose of entrectinib after consumption of a standardized meal.", 'detailedDescription': 'Participants with reduced hepatic function will be assigned to a functional category based on assessments at the Screening visit. Each individual will be categorized according to the Child Pugh system for classifying hepatic impairment and also according to the National Cancer Institute organ dysfunction working group (NCI-ODWG) system. Recruitment will be staggered to allow review of pharmacokinetic and safety data from at least three participants in each of the Mild and Moderate groups before participants are enrolled into the Severe group. Recruitment of the Severe group will only proceed if there is agreement between the Sponsor and the Investigator that data from this group are necessary to fulfill the objectives of the study and that dosing is not anticipated to present an unacceptable risk to those individuals. The control group of participants with normal hepatic function will be enrolled after the full complement of participants with hepatic dysfunction has been dosed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants:\n\n* A body mass index (BMI) between 18.0 and 38.0 kg/m2, and weighing at least 50 kg\n* Agreement to comply with measures to prevent pregnancy and restrictions on sperm donation.\n\nParticipants with normal hepatic function:\n\n* Normal hepatic function and no history of clinically significant hepatic dysfunction.\n* Healthy for age-group in the opinion of the Investigator.\n\nParticipants with hepatic impairment:\n\n* Mild, moderate or severe hepatic dysfunction (i.e. Child-Pugh A, B or C, NCIODWG Mild, Moderate or Severe) arising from cirrhosis of the liver as the result of parenchymal liver disease.\n* Stable hepatic function.\n\nExclusion Criteria:\n\n* Transjugular intrahepatic portosystemic shunt or other porta-caval shunt.\n* A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers.\n* Recent history or signs of severe hepatic encephalopathy (e.g., a portal systemic encephalopathy score \\>2).\n* Advanced ascites or ascites which require emptying and albumin supplementation.\n* Hepatocellular carcinoma, acute liver disease or serum ALT or AST not consistent with stable disease.\n* Recipient of a liver transplant.\n* Uncontrolled hypertension.\n* Clinically significant impairment of renal function.\n* A history of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract.\n* Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness.\n* Women who are pregnant or lactating.\n* Presence of any abnormal ECG finding, which is clinically significant.\n* Use of moderate or potent inhibitors or inducers of cytochrome P450 3A4 enzyme.\n* Participation in any other clinical study involving administration of an investigational medicinal product or use of an unapproved device.\n* A positive test result for human immunodeficiency virus (HIV).\n* Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds or other excipients in the entrectinib formulation.'}, 'identificationModule': {'nctId': 'NCT04226833', 'briefTitle': 'A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, One Treatment, Four Group, Parallel Group Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function', 'orgStudyIdInfo': {'id': 'GP41174'}, 'secondaryIdInfos': [{'id': '2019-003065-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild', 'description': 'Participants with mild hepatic impairment will receive 1x100 milligram (mg) F06 (entrectinib) capsule administered orally with approximately 240 milliliter (mL) water within 30 minutes after consumption of a standardized meal.', 'interventionNames': ['Drug: entrectinib']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate', 'description': 'Participants with moderate hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.', 'interventionNames': ['Drug: entrectinib']}, {'type': 'EXPERIMENTAL', 'label': 'Severe', 'description': 'Participants with severe hepatic impairment will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.', 'interventionNames': ['Drug: entrectinib']}, {'type': 'EXPERIMENTAL', 'label': 'Normal', 'description': 'Participants with normal hepatic function will receive 1x100 mg F06 (entrectinib) capsule administered orally with approximately 240 mL water within 30 minutes after consumption of a standardized meal.', 'interventionNames': ['Drug: entrectinib']}], 'interventions': [{'name': 'entrectinib', 'type': 'DRUG', 'otherNames': ['F06 formulation', 'Rozlytrek'], 'description': '1x100 milligram (mg) capsule given with approximately 240 milliliter (mL) of water within 30 minutes of consumption of a standardized meal', 'armGroupLabels': ['Mild', 'Moderate', 'Normal', 'Severe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '170 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Pharmaceutical Research Associates CZ, s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'CRU Hungary Kft', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '831 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Summit Clinical Research s.r.o.; Oddelenie internej mediciny a klinickej farmakologie', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}