Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT06021951
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2023-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@esperion.com', 'phone': '1-833-377-7633', 'title': 'Medical Director', 'organization': 'Esperion Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 43', 'description': 'Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Bempedoic Acid', 'description': 'Participants received bempedoic acid 180 mg oral tablet for 6 days', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bempedoic Acid / Ezetimibe FCDP', 'description': 'Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Daily Infant Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'Bempedoic Acid (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG002', 'title': 'Ezetimibe (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0331', 'spread': '0.0210', 'groupId': 'OG000'}, {'value': '0.0337', 'spread': '0.0286', 'groupId': 'OG001'}, {'value': '0.0002', 'spread': '0.0002', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.', 'unitOfMeasure': 'Milligrams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set comprised of all participants in Full Analysis Set who had at least 1 evaluable post-dosing breast milk bempedoic acid pharmacokinetic concentration data point.'}, {'type': 'PRIMARY', 'title': 'Relative Infant Dose (RID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bempedoic Acid', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'Bempedoic Acid (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG002', 'title': 'Ezetimibe (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4790', 'spread': '0.1962', 'groupId': 'OG000'}, {'value': '0.4678', 'spread': '0.2889', 'groupId': 'OG001'}, {'value': '0.0370', 'spread': '0.0097', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Relevant Infant Dose (RID) (calculated as the ratio of estimated infant daily dose per kg body weight and maternal daily dose per kg of body weight multiplied by 100) was analyzed for the Bempedoic Acid arm and FCDP arm respectively. Maternal dosage is the ratio of bempedoic acid dose or ezetimibe dose administered daily divided by maternal body weight at baseline.', 'unitOfMeasure': 'Percentage of maternal dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '33120.0', 'spread': '21034.11', 'groupId': 'OG000'}, {'value': '14207.4', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '20690.5', 'spread': '6554.48', 'groupId': 'OG002'}, {'value': '33673.4', 'spread': '28635.66', 'groupId': 'OG003'}, {'value': '770.0', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '20709.1', 'spread': '16012.78', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cumulative amount of ETC-1002, ESP-15228, and ETC-1002-glucuronide excreted in breast milk during the 24-hour collection period were analyzed for the Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Nanograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '182.2', 'spread': '154.97', 'groupId': 'OG000'}, {'value': '983.0', 'spread': '996.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cumulative amount of Ezetimibe, and EZE-glucuronide excreted in breast milk during 24-hour collection period were analyzed (FCDP arm only).', 'unitOfMeasure': 'Nanograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '118.15', 'spread': '38.91', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '73.06', 'spread': '56.59', 'groupId': 'OG002'}, {'value': '107.46', 'spread': '43.19', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '57.29', 'spread': '56.35', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Cmax of Ezetimibe and Metabolite in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '44.29', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '54.02', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cmax of Ezetimibe, and EZE-glucuronide analyzed in FCDP arm only.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '6.0'}, {'value': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.92', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '12.0'}, {'value': '2.93', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '8.9'}, {'value': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.93', 'groupId': 'OG005', 'lowerLimit': '5.8', 'upperLimit': '19.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Tmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Tmax of Ezetimibe and Metabolite in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '6.0'}, {'value': '5.88', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '8.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Tmax of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '1765.86', 'spread': '40.88', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '1308.84', 'spread': '56.24', 'groupId': 'OG002'}, {'value': '1618.25', 'spread': '39.67', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '1057.69', 'spread': '43.21', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'AUC24h of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Hours*nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'AUC24h of Ezetimibe and Metabolite in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '7.79', 'spread': '38.29', 'groupId': 'OG000'}, {'value': '41.09', 'spread': '66.10', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'AUC24h of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.', 'unitOfMeasure': 'Hours*nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '74.181', 'spread': '40.75', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '54.982', 'spread': '55.98', 'groupId': 'OG002'}, {'value': '67.848', 'spread': '39.77', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '44.346', 'spread': '43.42', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cavg (defined as AUC24h/24h) of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Cavg of Ezetimibe and Metabolite in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.327', 'spread': '38.41', 'groupId': 'OG000'}, {'value': '1.723', 'spread': '66.03', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cavg of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '50.58', 'spread': '47.59', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '45.55', 'spread': '62.72', 'groupId': 'OG002'}, {'value': '58.60', 'spread': '53.36', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '39.32', 'spread': '51.81', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_milk of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Ezetimibe and Metabolite in Breast Milk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '38.66', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '82.37', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_milk of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Bempedoic Acid and Metabolites in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '10025.6', 'spread': '25.46', 'groupId': 'OG000'}, {'value': '1862.4', 'spread': '34.04', 'groupId': 'OG001'}, {'value': '4904.9', 'spread': '35.65', 'groupId': 'OG002'}, {'value': '9665.9', 'spread': '37.95', 'groupId': 'OG003'}, {'value': '1641.8', 'spread': '20.78', 'groupId': 'OG004'}, {'value': '4984.7', 'spread': '35.65', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_plasma of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Ctrough of Ezetimibe and Metabolite in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'spread': '69.37', 'groupId': 'OG000'}, {'value': '35.76', 'spread': '77.54', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_plasma of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'ETC-1002', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG001', 'title': 'ESP-15228', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG002', 'title': 'ETC-1002-Glucuronide', 'description': 'Bempedoic Acid Arm'}, {'id': 'OG003', 'title': 'ETC-1002 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG004', 'title': 'ESP-15228 (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG005', 'title': 'ETC-1002-Glucuronide (FCDP)', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '25.35', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG001'}, {'value': '0.009', 'spread': '29.05', 'groupId': 'OG002'}, {'value': '0.006', 'spread': '59.39', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\\<20.0) at all nominal timepoints.', 'groupId': 'OG004'}, {'value': '0.008', 'spread': '63.91', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'M/P Ratio of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.'}, {'type': 'SECONDARY', 'title': 'M/P Ratio of Ezetimibe and Metabolite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}, {'id': 'OG001', 'title': 'EZE-Glucuronide', 'description': 'Bempedoic Acid / Ezetimibe FCDP Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '0.108', 'spread': '62.21', 'groupId': 'OG000'}, {'value': '0.037', 'spread': '81.68', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'M/P Ratio of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bempedoic Acid', 'description': 'Participants received bempedoic acid 180 mg oral tablet for 6 days'}, {'id': 'FG001', 'title': 'Bempedoic Acid/Ezetimibe FCDP', 'description': 'Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a Phase 4, open-label study that estimated the daily infant dosage and relative infant dose (RID) for bempedoic acid and bempedoic acid/ezetimibe fixed combination drug product (FCDP) and characterized the excretion of bempedoic acid (ETC-1002), ezetimibe, and metabolites ESP-15228, ETC-1002-glucuronide, and ezetimibe-glucuronide in the mature breast milk of healthy women.', 'preAssignmentDetails': 'A total of 16 subjects were enrolled into the study and randomized in a 1:1 ratio to receive bempedoic acid 180 milligrams (mg) or bempedoic acid 180 mg/ezetimibe 10 mg FCDP'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bempedoic Acid', 'description': 'Participants received bempedoic acid 180 mg oral tablet for 6 days'}, {'id': 'BG001', 'title': 'Bempedoic Acid/Ezetimibe FCDP', 'description': 'Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '4.17', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '4.09', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '5.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Full Analysis Set comprised of all randomized participants who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-06', 'size': 948315, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-25T00:45', 'hasProtocol': True}, {'date': '2024-06-26', 'size': 567553, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-25T00:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-08-27', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2023-08-27', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-25', 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Infant Dose', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.'}, {'measure': 'Relative Infant Dose (RID)', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Relevant Infant Dose (RID) (calculated as the ratio of estimated infant daily dose per kg body weight and maternal daily dose per kg of body weight multiplied by 100) was analyzed for the Bempedoic Acid arm and FCDP arm respectively. Maternal dosage is the ratio of bempedoic acid dose or ezetimibe dose administered daily divided by maternal body weight at baseline.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cumulative amount of ETC-1002, ESP-15228, and ETC-1002-glucuronide excreted in breast milk during the 24-hour collection period were analyzed for the Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cumulative amount of Ezetimibe, and EZE-glucuronide excreted in breast milk during 24-hour collection period were analyzed (FCDP arm only).'}, {'measure': 'Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively'}, {'measure': 'Cmax of Ezetimibe and Metabolite in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cmax of Ezetimibe, and EZE-glucuronide analyzed in FCDP arm only.'}, {'measure': 'Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Tmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively'}, {'measure': 'Tmax of Ezetimibe and Metabolite in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Tmax of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.'}, {'measure': 'Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'AUC24h of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'AUC24h of Ezetimibe and Metabolite in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'AUC24h of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.'}, {'measure': 'Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cavg (defined as AUC24h/24h) of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'Cavg of Ezetimibe and Metabolite in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Cavg of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.'}, {'measure': 'Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_milk of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'Ctrough of Ezetimibe and Metabolite in Breast Milk', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_milk of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.'}, {'measure': 'Ctrough of Bempedoic Acid and Metabolites in Plasma', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_plasma of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'Ctrough of Ezetimibe and Metabolite in Plasma', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'Ctrough\\_plasma of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.'}, {'measure': 'Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'M/P Ratio of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.'}, {'measure': 'M/P Ratio of Ezetimibe and Metabolite', 'timeFrame': '24 hours post Day 6 dose administration', 'description': 'M/P Ratio of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bempedoic acid', 'Ezetimibe', 'Bempedoic acid and ezetimibe', 'Breast Milk'], 'conditions': ['Healthy Lactating Women']}, 'descriptionModule': {'briefSummary': 'This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.', 'detailedDescription': 'Post marketing approval commitment for the FDA'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject must be a lactating female who had a normal full-term pregnancy and has been actively breastfeeding or pumping for at least 4 weeks; lactation must be well established per Investigator discretion.\n* The subject must be willing to pump regularly during the study to maintain milk supply and discontinue breastfeeding for the entire 13-day Treatment and Washout Periods.\n* The subject must not be pregnant.\n* The subject must be surgically sterile or willing to use 1 acceptable method of birth control.\n\nExclusion Criteria:\n\n* Has clinically significant infection (e.g., pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.\n* Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash, that, in the opinion of the Investigator, would confound the study results or compromise subject safety.\n* Has estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.732 using the Modification of Diet in Renal Disease (MDRD) formula.\n* Has liver disease or dysfunction characterized by Child-Pugh Class B or Class C.\n* History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.\n* Has active psychiatric problems that, in the Investigator's opinion, may interfere with compliance with the study procedures.\n* Has history of breast implants, breast augmentation, or breast reduction surgery.\n* Has a prior history of difficulty establishing lactation.\n* Gastrointestinal conditions or procedures (including weight loss surgery; e.g., Lap-Band® or gastric bypass) that may affect drug absorption.\n* Any history of malignancy (with the exception only of basal or squamous cell carcinoma of the skin in individuals that have been cancer free for \\>5 years).\n* History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse.\n* Current smoker.\n* Blood donation, participation in a multiple blood draw clinical study, major trauma, or surgery with or without blood loss within 30 days prior to enrollment.\n* Blood transfusion for any reason within 90 days prior to enrollment.\n* Use of any 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor (statin) concurrently or within 30 days prior to randomization.\n* Use of cyclosporine, cholestyramine, probenecid, fibrate drugs, or medications contraindicated during lactation concurrently or within 30 days prior to randomization.\n* Concomitant use or use within 30 days prior to randomization of drugs that decrease breast milk production, such as pseudoephedrine.\n* Concomitant use or use within 30 days prior to randomization of drugs that increase breast milk production, such as domperidone.\n* Use of any experimental or investigational drugs/vaccines concurrently or within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening."}, 'identificationModule': {'nctId': 'NCT06021951', 'briefTitle': 'Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)', 'orgStudyIdInfo': {'id': '1002FDC-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bempedoic acid', 'interventionNames': ['Drug: Bempedoic Acid 180 MG Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Bempedoic acid/ezetimibe fixed combination drug product', 'interventionNames': ['Drug: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet']}], 'interventions': [{'name': 'Bempedoic Acid 180 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['Nexletol'], 'description': 'Bempedoic Acid 180 MG Oral Tablet \\[Nexletol\\]', 'armGroupLabels': ['Bempedoic acid']}, {'name': 'Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['Nexlizet 180 mg-10 mg'], 'description': 'Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet \\[NEXLIZET\\]', 'armGroupLabels': ['Bempedoic acid/ezetimibe fixed combination drug product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'PPD Development, Las Vegas Research Unit', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Christine Broestl, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Esperion Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}