Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT04120233
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2019-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MW151-101: First-in-human Study of MW151
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575875', 'term': '2-(4-(4-methyl-6-phenylpyridazin-3-yl)piperazin-1-yl)pyrimidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linda.vaneldik@uky.edu', 'phone': '1-859-257-5566', 'title': 'Dr. Linda J. Van Eldik', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of study drug administration up to 7-day follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing Drug-related Serious Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Seven days', 'description': 'Percentage of participants experiencing drug-related serious adverse events from the start of study drug administration up to 7-day follow-up.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Drug Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '132.0', 'spread': '62.5', 'groupId': 'OG002'}, {'value': '283.0', 'spread': '244', 'groupId': 'OG003'}, {'value': '361.0', 'spread': '53.2', 'groupId': 'OG004'}, {'value': '1190.0', 'spread': '707.0', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Peak serum concentration of MW151.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement.\n\nOne subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint.\n\nPK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Drug Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '1.4', 'groupId': 'OG004'}, {'value': '2.0', 'spread': '1.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Time required to reach the maximum serum concentration of MW151.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement.\n\nOne subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint.\n\nPK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Drug Exposure (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '208.0', 'spread': '91.8', 'groupId': 'OG001'}, {'value': '741.0', 'spread': '168.0', 'groupId': 'OG002'}, {'value': '1250.0', 'spread': '453.0', 'groupId': 'OG003'}, {'value': '3120.0', 'spread': '1290.0', 'groupId': 'OG004'}, {'value': '7590.0', 'spread': '1800.0', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Overall drug exposure (h\\*ng/mL) determined by calculating the area under the curve (AUC) from a plasma drug concentration-time curve.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who were administered MW151 and had at least 1 quantifiable concentration of MW151 measurement.\n\nOne subject in Cohort 4 withdrew prior to the 36h plasma sampling, so that sampling point was excluded from the PK dataset at that timepoint.\n\nPK parameters for MW151 cannot be analyzed in the placebo group, as they did not receive the study drug.'}, {'type': 'SECONDARY', 'title': 'Drug Half-Life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '8.8', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG003'}, {'value': '10.4', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG004'}, {'value': '10.6', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Time at which the concentration of MW151 is at half the maximum concentration.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Placebo: PK parameters for MW151 cannot be analyzed, as they did not receive the study drug.\n\nDose 2: Data from two participants were excluded for being nonacceptable, and were not analyzed.\n\nDose 3, 4 and 5: Data from 5 participants in each group were nonacceptable, and were not analyzed.\n\nNon-acceptance data are defined as: R\\^2\\_adjusted \\<0.8 and terminal elimination phase time span \\<3 half-lives after Tmax.'}, {'type': 'SECONDARY', 'title': 'Elimination Rate Constant (Kel)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'OG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'OG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'OG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'OG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'OG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.08', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG003'}, {'value': '0.07', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG004'}, {'value': '0.07', 'spread': 'NA', 'comment': 'Only one participant did not have non-acceptance data. Since data from only one participant was analyzed the deviation cannot be calculated.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Fraction of MW151 eliminated per unit of time (mathematical determination).', 'unitOfMeasure': '1/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Placebo: PK parameters for MW151 cannot be analyzed, as they did not receive the study drug.\n\nDose 2: Data from two participants were excluded for being nonacceptable, and were not analyzed.\n\nDose 3, 4 and 5: Data from 5 participants in each group were nonacceptable, and were not analyzed.\n\nNon-acceptance data are defined as: R\\^2\\_adjusted \\<0.8 and terminal elimination phase time span \\<3 half-lives after Tmax.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'FG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'FG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'FG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'FG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'FG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was initiated on October 11, 2019 and last follow-up was completed on September 16,2021.', 'preAssignmentDetails': 'A total of 97 subjects were screened and 40 subjects were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants will receive placebo.\n\nPlacebo: Matched placebo administered orally'}, {'id': 'BG001', 'title': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.\n\nMW151, 10mg: 10 mg MW151, 1 x 10mg capsule administered orally'}, {'id': 'BG002', 'title': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.\n\nMW151, 20mg: 20 mg MW151, 1 x 20mg capsule administered orally'}, {'id': 'BG003', 'title': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.\n\nMW151, 40mg: 40 mg MW151, 2 x 20mg capsule administered orally'}, {'id': 'BG004', 'title': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.\n\nMW151, 80mg: 80 mg MW151, 1 x 80mg capsule administered orally'}, {'id': 'BG005', 'title': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.\n\nMW151, 160mg: 160 mg MW151, 2 x 80mg capsule administered orally'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '34.5', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '40.9', 'spread': '6.4', 'groupId': 'BG004'}, {'value': '35.2', 'spread': '7.4', 'groupId': 'BG005'}, {'value': '36.8', 'spread': '8.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.3', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '178.1', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '158.0', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '162.5', 'spread': '1.9', 'groupId': 'BG003'}, {'value': '169.3', 'spread': '7.5', 'groupId': 'BG004'}, {'value': '165.1', 'spread': '4.3', 'groupId': 'BG005'}, {'value': '165.9', 'spread': '8.5', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.8', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '85.3', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '68.1', 'spread': '7.6', 'groupId': 'BG003'}, {'value': '79.6', 'spread': '17.4', 'groupId': 'BG004'}, {'value': '75.1', 'spread': '10.2', 'groupId': 'BG005'}, {'value': '75.5', 'spread': '13.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '25.8', 'spread': '2.6', 'groupId': 'BG003'}, {'value': '27.5', 'spread': '4.3', 'groupId': 'BG004'}, {'value': '27.6', 'spread': '4.0', 'groupId': 'BG005'}, {'value': '27.4', 'spread': '3.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-13', 'size': 1646094, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-11-01T15:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data from cohorts will be reviewed in a blinded manner.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose-escalation study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2019-10-07', 'resultsFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-07', 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Drug-related Serious Adverse Events.', 'timeFrame': 'Seven days', 'description': 'Percentage of participants experiencing drug-related serious adverse events from the start of study drug administration up to 7-day follow-up.'}], 'secondaryOutcomes': [{'measure': 'Maximum Drug Concentration (Cmax)', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Peak serum concentration of MW151.'}, {'measure': 'Time to Maximum Drug Concentration (Tmax)', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Time required to reach the maximum serum concentration of MW151.'}, {'measure': 'Overall Drug Exposure (AUC)', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Overall drug exposure (h\\*ng/mL) determined by calculating the area under the curve (AUC) from a plasma drug concentration-time curve.'}, {'measure': 'Drug Half-Life (T1/2)', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Time at which the concentration of MW151 is at half the maximum concentration.'}, {'measure': 'Elimination Rate Constant (Kel)', 'timeFrame': 'predose, 0.25h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h and 36h post-dose', 'description': 'Fraction of MW151 eliminated per unit of time (mathematical determination).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive disorder', 'pharmacokinetics', 'MW151', 'MW01-2-151SRM', 'PK', 'dose escalation'], 'conditions': ['Drug Toxicity']}, 'descriptionModule': {'briefSummary': "MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of radiation-induced cognitive impairment, Alzheimer's disease, and other central nervous system (CNS) disorders.\n\nThe present study will provide safety and pharmacokinetic (PK) information on single ascending doses to support decisions for continued clinical development.", 'detailedDescription': 'The primary objective of this trial is to assess the safety and tolerability of single ascending doses of MW151 when administered orally to healthy adults.\n\nSubjects will be screened prior to inpatient admission. Subjects will be admitted to the inpatient clinic on the day prior to dosing (Day -1) and will remain in the unit until discharge on Day 3. A follow-up visit will be done on Day 7. A single dose of study drug or placebo will be administered on Day 1. Healthy adult female subjects will be randomly assigned to one of 5 dose cohorts (8 subjects each). Each subject will receive a single dose of MW151 (10-160mg) or placebo under fasted conditions.\n\nFollowing a review of safety and tolerability data for the first 24 hours of dosing in each cohort (including reported adverse events (AEs), physical examination findings, clinical laboratory results, vital signs, and electrocardiograms (ECGs), the remaining 6 subjects will be randomized in a 5:1 ratio. Dosing of the remaining subjects in a cohort may proceed after review of sentinel subject safety data collected during the first 24 hours of dosing and determination that no stopping rules are met. The remaining subjects in each cohort will be dosed sequentially, not simultaneously.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs.\n* Weight \\>50kg\n* BMI \\<34 kg/m2.\n* ECG without clinically significant pathologic abnormalities and with QTcF \\<450 ms -\n* Systolic BP ≤ 150 mmHg and diastolic BP ≤ 90 mmHg at screening\n* No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS).\n* Women who are neither pregnant (negative pregnancy test) nor nursing, and are either: surgically sterile, postmenopausal with last natural menses greater than 24 months, or premenopausal and agrees to use and acceptable form of birth control during the study and for 1 month after dosing.\n* Adequate venous access for blood draws.\n\nExclusion Criteria:\n\n* Any unstable chronic medical condition requiring interventional treatment that might increase the risk to the subject or confound interpretation of safety observations. Subjects who are considered stable and who have been receiving stable treatment for medical condition for \\> 3 months may be considered with approval of medical monitor.\n* Evidence of active infection requiring antibiotic therapy within 14 days prior to dosing.\n* Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.\n* History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.\n* Seropositive for human immunodeficiency virus (HIV).\n* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B\n* Clinically significant abnormalities in screening laboratory tests\n* Over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements and ocular medications at the discretion of the Investigator). Stable doses (\\> to 3 months of stable dose) of prescription medications are allowed with the approval of the medical monitor (birth control medications are allowed without medical monitor approval). Subjects should not be on non-steroidal anti-inflammatory drugs or immunosuppressive drugs within 10 days prior to dosing.\n* Use of known CYP450 CYP1A2, CYP2D6 or CYP3A4 inhibitors or inducers within 14 days of dosing or planned use during the study.\n* Use of an investigational drug, vaccine, device, or blood product within 3 months prior to dosing in this study.\n* Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn\'s disease, celiac disease, or liver disease.)\n* Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.\n* History of substance abuse including alcohol within the past 5 years.\n* Smoker.\n* Current substance or drug dependence confirmed by positive urine drug screen at screening visit or Day -1 admission.\n* Current alcohol abuse confirmed by positive breathalyzer at screening visit or Day -1 admission.\n* History of serious head injury as determined by the site investigator or designee.\n* Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of \\<60 ml/min using the MDRD formula).\n* Any reason or opinion of the investigator that would prevent the subject from participation in the study.\n* Inability to follow the instructions or an unwillingness to cooperate with study procedures.\n* Has donated more than 500 mL of blood within the last month prior to dosing.'}, 'identificationModule': {'nctId': 'NCT04120233', 'briefTitle': 'MW151-101: First-in-human Study of MW151', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'A Phase 1a, Double-Blind, Randomized, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of MW151 Administered Orally to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Pro00103072, IND143222'}, 'secondaryIdInfos': [{'id': 'R01AG061898', 'link': 'https://reporter.nih.gov/quickSearch/R01AG061898', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 1', 'description': 'Participants will receive 10 mg of MW151.', 'interventionNames': ['Drug: MW151, 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2', 'description': 'Participants will receive 20mg of MW151.', 'interventionNames': ['Drug: MW151, 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3', 'description': 'Participants will receive 40mg of MW151.', 'interventionNames': ['Drug: MW151, 40mg']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4', 'description': 'Participants will receive 80mg of MW151.', 'interventionNames': ['Drug: MW151, 80mg']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 5', 'description': 'Participants will receive 160mg of MW151.', 'interventionNames': ['Drug: MW151, 160mg']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo administered orally', 'armGroupLabels': ['Placebo']}, {'name': 'MW151, 10mg', 'type': 'DRUG', 'description': '10 mg MW151, 1 x 10mg capsule administered orally', 'armGroupLabels': ['Dose 1']}, {'name': 'MW151, 20mg', 'type': 'DRUG', 'description': '20 mg MW151, 1 x 20mg capsule administered orally', 'armGroupLabels': ['Dose 2']}, {'name': 'MW151, 40mg', 'type': 'DRUG', 'description': '40 mg MW151, 2 x 20mg capsule administered orally', 'armGroupLabels': ['Dose 3']}, {'name': 'MW151, 80mg', 'type': 'DRUG', 'description': '80 mg MW151, 1 x 80mg capsule administered orally', 'armGroupLabels': ['Dose 4']}, {'name': 'MW151, 160mg', 'type': 'DRUG', 'description': '160 mg MW151, 2 x 80mg capsule administered orally', 'armGroupLabels': ['Dose 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Clinical Research Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Linda J Van Eldik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linda Van Eldik', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Sanders-Brown Center on Aging', 'investigatorFullName': 'Linda Van Eldik', 'investigatorAffiliation': 'University of Kentucky'}}}}