Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02802735
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C505730', 'term': 'apremilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1, up to 40 days; Part 2, up to 24 days', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.', 'otherNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.', 'otherNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1: Total', 'description': 'Participants received a single oral dose of 20 mg apremilast, 30 mg apremilast, and 40 mg apremilast across 3 treatment periods separated by a washout period of 7-10 days.', 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day for 14 days.', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2: Placebo BID', 'description': 'Participants received matching placebo orally twice a day for 14 days.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2: Total', 'description': 'Participants who received 30 mg apremilast or placebo twice a day for 14 days', 'otherNumAtRisk': 16, 'otherNumAffected': 10, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '273', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '373', 'spread': '19.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'description': 'Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '1770', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '2330', 'spread': '22.6', 'groupId': 'OG001'}, {'value': '3470', 'spread': '25.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '1790', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '2360', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '3500', 'spread': '25.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Terminal Elimination Half-life (T1/2) for Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '44.4', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '36.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '25.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '47.6', 'groupId': 'OG000'}, {'value': '151', 'spread': '49.6', 'groupId': 'OG001'}, {'value': '122', 'spread': '38.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'unitOfMeasure': 'liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Area Under the Plasma Concentration-time Curve During a Dosage Interval (AUCτ) for Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1610', 'spread': '33.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2600', 'spread': '34.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose', 'description': 'Area under the plasma concentration-time curve during a dosage interval (tau) at steady state, where tau is 12 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '283', 'spread': '34.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '408', 'spread': '36.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Terminal Elimination Half-life (T1/2) for Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.80', 'spread': '31.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '34.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose', 'unitOfMeasure': 'liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'spread': '53.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose', 'unitOfMeasure': 'liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'PRIMARY', 'title': 'Part 2: Ratio of Accumulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day (BID) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '36.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose, and on day 14 only at 24, 36, 48, 60, and 72 hours after the morning dose', 'description': 'Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast and had at least 1 measurable concentration datum.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Apremilast 20 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast.'}, {'id': 'OG001', 'title': 'Part 1: Apremilast 30 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast.'}, {'id': 'OG002', 'title': 'Part 1: Apremilast 40 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast.'}, {'id': 'OG003', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day for 14 days.'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID', 'description': 'Participants received matching placebo orally twice a day for 14 days.'}], 'classes': [{'title': 'Any treatment-emergent adverse event (TEAE)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'TEAE related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Serious adverse events related o study dug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'TEAE leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Treatment-related TEAE leading to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1, up to 40 days; Part 2, up to 24 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of apremilast.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Apremilast 20 mg / 30 mg / 40 mg', 'description': 'Participants received a single oral dose of 20 mg apremilast on day 1 of period 1, a single oral dose of 30 mg apremilast on day 1 of period 2, and a single oral dose of 40 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.'}, {'id': 'FG001', 'title': 'Part 1: Apremilast 30 mg / 20 mg / 40 mg', 'description': 'Participants received a single oral dose of 30 mg apremilast on day 1 of period 1, a single oral dose of 20 mg apremilast on day 1 of period 2, and a single oral dose of 40 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.'}, {'id': 'FG002', 'title': 'Part 1: Apremilast 40 mg / 20 mg / 30 mg', 'description': 'Participants received a single oral dose of 40 mg apremilast on day 1 of period 1, a single oral dose of 20 mg apremilast on day 1 of period 2, and a single oral dose of 30 mg apremilast on day 1 of period 3. There was a 7-10 day washout period between each dose.'}, {'id': 'FG003', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day for 14 days.'}, {'id': 'FG004', 'title': 'Part 2: Placebo BID', 'description': 'Participants received matching placebo orally twice a day for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a two-part study in healthy Korean men. The study was conducted at 1 clinic in Korea.', 'preAssignmentDetails': 'In Part 1 participants were randomized to 1 of 3 treatment sequences consisting of 3 treatment periods.\n\nIn Part 2 participants were randomized in a 3:1 ratio to receive apremilast or matching placebo twice a day (BID) for 14 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Apremilast', 'description': 'Participants received a single oral dose of 20 mg apremilast, 30 mg apremilast, and 40 mg apremilast across 3 treatment periods separated by a washout period of 7-10 days.'}, {'id': 'BG001', 'title': 'Part 2: Apremilast 30 mg BID', 'description': 'Participants received 30 mg apremilast orally twice a day for 14 days.'}, {'id': 'BG002', 'title': 'Part 2: Placebo BID', 'description': 'Participants received matching placebo orally twice a day for 14 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'BG000', 'lowerLimit': '19.0', 'upperLimit': '43.0'}, {'value': '30.8', 'groupId': 'BG001', 'lowerLimit': '24.0', 'upperLimit': '41.0'}, {'value': '25.5', 'groupId': 'BG002', 'lowerLimit': '20.0', 'upperLimit': '31.0'}, {'value': '29.6', 'groupId': 'BG003', 'lowerLimit': '19.0', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Part 1 was a randomized open-label crossover study. Part 2 was a randomized, double-blind study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part 1 of the study was a 3-treatment period, 3-sequence crossover study. Part 2 was a parallel-group, placebo-controlled, single-period study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2016-06-14', 'resultsFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-14', 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of Apremilast', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.', 'description': 'Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.'}, {'measure': 'Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Apremilast', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 1: Terminal Elimination Half-life (T1/2) for Apremilast', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 1: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 1: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)', 'timeFrame': 'Day 1 of each treatment period at predose (0 hour) and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours post-dose.'}, {'measure': 'Part 2: Area Under the Plasma Concentration-time Curve During a Dosage Interval (AUCτ) for Apremilast', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose', 'description': 'Area under the plasma concentration-time curve during a dosage interval (tau) at steady state, where tau is 12 hours.'}, {'measure': 'Part 2: Maximum Observed Plasma Concentration (Cmax) of Apremilast', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose'}, {'measure': 'Part 2: Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose'}, {'measure': 'Part 2: Terminal Elimination Half-life (T1/2) for Apremilast', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose'}, {'measure': 'Part 2: Apparent Clearance of Apremilast From Plasma After Extravascular Administration (CL/F)', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose'}, {'measure': 'Part 2: Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)', 'timeFrame': 'Day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60, and 72 hours after the morning dose'}, {'measure': 'Part 2: Ratio of Accumulation', 'timeFrame': 'Day 1 and day 14 prior to the morning dose (0 hour), and at 0.5, 1, 1.5, 2, 3, 5, 8, and 12 hours after the morning dose, and on day 14 only at 24, 36, 48, 60, and 72 hours after the morning dose', 'description': 'Ratio of accumulation calculated as Day 14 AUC0-τ / Day 1 AUC0-τ'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (AEs)', 'timeFrame': 'Part 1, up to 40 days; Part 2, up to 24 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Apremilast', 'Healthy Adult Male', 'Korean Subjects'], 'conditions': ['Pharmacokinetics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT02802735?term=CC-10004-CP-033&rank=1', 'label': 'Expanded Access for CC-10004'}]}, 'descriptionModule': {'briefSummary': 'This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.', 'detailedDescription': 'The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Subjects must satisfy the following criteria to be enrolled in the study:\n\n1. Healthy adult male Korean subjects between 18 and 45 years of age (inclusive) at the time of signing the informed consent form (ICF).\n2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.\n3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n4. Must be able to communicate with the Investigator and understand and comply with the requirements of the study.\n5. Must be in good health as determined by the Investigator according to past medical history, physical examination (PE), vital signs, 12-lead electrocardiogram (ECG), and laboratory tests.\n6. Must have a body mass index (BMI) between 18 and 30 kg/m\\^2 (inclusive).\n7. Clinical laboratory tests must be within normal limits or considered by the Investigator to be not clinically significant.\n8. Vital signs (systolic and diastolic blood pressure, pulse rate, and oral \\[or tympanic\\] body temperature) will be assessed in the supine position after the subject has rested for at least five minutes. Subject must be afebrile (febrile \\[oral or tympanic\\] is defined as ≥ 38°C or 100.3°F) with vital signs within the following ranges:\n\n * Systolic blood pressure: 90 to 140 mm Hg;\n * Diastolic blood pressure: 50 to 90 mm Hg;\n * Pulse rate: 40 to 110 bpm.\n9. Must have a normal or clinically acceptable 12-lead ECG. Subjects must have a QTc value ≤ 450 msec.\n10. Must have a normal or clinically acceptable physical examination.\n11. Contraception Requirements:\n\n \\- Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex or non-latex condoms NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]) while on Investigational Product (IP) and for at least 28 days after the last dose of investigational product (IP).\n12. Must agree to refrain from donating sperm, blood or plasma (other than for this study) while participating in this study, and for at least 28 days after the last dose of IP.\n\nExclusion Criteria:\n\n* The presence of any of the following will exclude any healthy subject from enrollment into the study:\n\n 1. History of any clinically significant and relevant neurological, psychiatric, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.\n 2. Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.\n 3. Use of any prescribed systemic or topical medication within 30 days of the first dose administration.\n 4. Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.\n 5. Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel syndrome, Crohn's disease, etc. Subjects with cholecystectomy and appendectomy may be included.\n 6. Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).\n 7. Donated blood or plasma within eight weeks before the first dose administration to a blood bank or blood donation center.\n 8. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \\[DSM\\]) within 2 years before dosing, or a positive drug screen reflecting consumption of illicit drugs.\n 9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen.\n 10. Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies, or have a positive result to the test for HBsAg, HCV antibodies or human immunodeficiency virus (HIV) antibodies at Screening."}, 'identificationModule': {'nctId': 'NCT02802735', 'briefTitle': 'Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1, Open-label, Two Part Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects', 'orgStudyIdInfo': {'id': 'CC-10004-CP-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Apremilast 20 mg', 'description': 'A single oral dose of 20 mg apremilast.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Apremilast 30 mg', 'description': 'A single oral dose of 30 mg apremilast.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Apremilast 40 mg', 'description': 'A single oral dose of 40 mg apremilast.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Apremilast 30 mg BID', 'description': '30 mg apremilast orally twice a day (BID) for 14 days.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo', 'description': 'Matching placebo orally twice a day for 14 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Apremilast', 'type': 'DRUG', 'otherNames': ['CC-10004', 'OTEZLA®'], 'description': 'Tablet for oral administration', 'armGroupLabels': ['Part 1: Apremilast 20 mg', 'Part 1: Apremilast 30 mg', 'Part 1: Apremilast 40 mg', 'Part 2: Apremilast 30 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet for oral administration', 'armGroupLabels': ['Part 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}