Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-09 @ 6:03 PM
Study NCT ID:
NCT05725005
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2022-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PET Study of Repeated ASN51 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials.gov@asceneuron.com', 'phone': '+ 41 21 353 8245', 'title': 'Asceneuron Clinical Research', 'organization': 'Asceneuron SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to end of the study (approximately 4.5 months)', 'description': 'Safety population included all participants who received at least one dose of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Protein O-GlcNAcylation in Peripheral Blood Mononuclear Cells (PBMCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Pre-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '100.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '219.33', 'spread': '74.728', 'groupId': 'OG000'}, {'value': '232.79', 'spread': '94.193', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '291.02', 'spread': '117.673', 'groupId': 'OG000'}, {'value': '190.48', 'spread': '56.442', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '183.83', 'spread': '84.144', 'groupId': 'OG000'}, {'value': '188.02', 'spread': '96.636', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose on Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '205.70', 'spread': '19.045', 'groupId': 'OG000'}, {'value': '188.30', 'spread': '126.761', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose on Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '302.19', 'spread': '49.840', 'groupId': 'OG000'}, {'value': '346.01', 'spread': '233.011', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose on day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '196.42', 'spread': '99.330', 'groupId': 'OG000'}, {'value': '197.54', 'spread': '98.510', 'groupId': 'OG001'}]}]}, {'title': '8 hours post-dose on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '297.01', 'spread': '119.672', 'groupId': 'OG000'}, {'value': '282.51', 'spread': '151.609', 'groupId': 'OG001'}]}]}, {'title': '12 hours post-dose on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '303.24', 'spread': '147.572', 'groupId': 'OG000'}, {'value': '305.26', 'spread': '167.261', 'groupId': 'OG001'}]}]}, {'title': '24 hours post-dose on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '166.19', 'spread': '62.638', 'groupId': 'OG000'}, {'value': '160.38', 'spread': '58.879', 'groupId': 'OG001'}]}]}, {'title': '72 hours post-dose on Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '169.66', 'spread': '45.654', 'groupId': 'OG000'}, {'value': '192.67', 'spread': '128.801', 'groupId': 'OG001'}]}]}, {'title': '144 hours post-dose on Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168.68', 'spread': '40.767', 'groupId': 'OG000'}, {'value': '187.14', 'spread': '126.539', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose on Days 1, 2, 11, and 14; 8 hours post-dose on Day 1, 11 and 14; 12 hours post-dose on Day 1 and 14, 24 hours post-dose on Day 15; 72 hours post-dose on Day 17; 144 hours post-dose on Day 20', 'description': 'Protein O-GlcNAcylation in PBMCs at different time-point is reported.', 'unitOfMeasure': 'percentage of protein O-GlcNAcylation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) analysis population included all participants in the safety population for who a PBMC measure is available. Number analyzed is the number of participants evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.47', 'groupId': 'OG000'}, {'value': '15.91', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000'}, {'value': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000'}, {'value': '3.67', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.81', 'groupId': 'OG000'}, {'value': '13.53', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000'}, {'value': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.81', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not reported as the PET scan findings failed to converge a meaningful VT.', 'groupId': 'OG000'}, {'value': '17.34', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000'}, {'value': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.77', 'groupId': 'OG000'}, {'value': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.62', 'groupId': 'OG000'}, {'value': '14.90', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.07', 'groupId': 'OG000'}, {'value': '2.11', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in frontal lobe at each brain scan was measured with a PET scan. Participants received an intravenous (IV) dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'milliliters/cubic centimeter(mL/cm^3)', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Anterior Cingulate at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.57', 'groupId': 'OG000'}, {'value': '18.51', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000'}, {'value': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000'}, {'value': '3.98', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.45', 'groupId': 'OG000'}, {'value': '16.08', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000'}, {'value': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.79', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.34', 'groupId': 'OG000'}, {'value': '20.14', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000'}, {'value': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000'}, {'value': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.87', 'groupId': 'OG000'}, {'value': '17.02', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000'}, {'value': '2.04', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in anterior cingulate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Caudate at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.25', 'groupId': 'OG000'}, {'value': '13.28', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000'}, {'value': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000'}, {'value': '2.97', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.89', 'groupId': 'OG000'}, {'value': '11.43', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000'}, {'value': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.98', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.77', 'groupId': 'OG000'}, {'value': '13.95', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.77', 'groupId': 'OG000'}, {'value': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000'}, {'value': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.50', 'groupId': 'OG000'}, {'value': '13.44', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.66', 'groupId': 'OG000'}, {'value': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.99', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Caudate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Putamen at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.74', 'groupId': 'OG000'}, {'value': '17.00', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000'}, {'value': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000'}, {'value': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.46', 'groupId': 'OG000'}, {'value': '15.89', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000'}, {'value': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.27', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.76', 'groupId': 'OG000'}, {'value': '20.70', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000'}, {'value': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000'}, {'value': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.88', 'groupId': 'OG000'}, {'value': '17.00', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000'}, {'value': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Putamen at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan.\n\nParticipant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Accumbens at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.16', 'groupId': 'OG000'}, {'value': '19.29', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000'}, {'value': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.51', 'groupId': 'OG000'}, {'value': '3.91', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.94', 'groupId': 'OG000'}, {'value': '16.58', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000'}, {'value': '2.66', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.18', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.57', 'groupId': 'OG000'}, {'value': '20.52', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000'}, {'value': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.80', 'groupId': 'OG000'}, {'value': '2.67', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.18', 'groupId': 'OG000'}, {'value': '18.65', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG000'}, {'value': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.09', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Accumbens at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Amygdala at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG000'}, {'value': '18.91', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000'}, {'value': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}, {'value': '4.42', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.84', 'groupId': 'OG000'}, {'value': '17.77', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000'}, {'value': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.25', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.37', 'groupId': 'OG000'}, {'value': '22.00', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.32', 'groupId': 'OG000'}, {'value': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000'}, {'value': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.77', 'groupId': 'OG000'}, {'value': '17.57', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'groupId': 'OG000'}, {'value': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Amygdala at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Regional VT of [18F]-IMA601 in Cerebral White Matter at Each Brain Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.39', 'groupId': 'OG000'}, {'value': '10.72', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000'}, {'value': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Participant 1, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.30', 'groupId': 'OG000'}, {'value': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.39', 'groupId': 'OG000'}, {'value': '10.15', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'groupId': 'OG000'}, {'value': '2.43', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Participant 2, PET Scan 3, Day 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.25', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.39', 'groupId': 'OG000'}, {'value': '12.86', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000'}, {'value': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Participant 3, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000'}, {'value': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 1, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000'}, {'value': '11.45', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000'}, {'value': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.34', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4, PET Scan 3, Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.34', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in cerebral white matter at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.', 'unitOfMeasure': 'mL/cm^3', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment. A TEAE is defined as an AE that emerges during treatment (having been absent before treatment) or that worsens after treatment. Serious TEAE is defined as any adverse event that is fatal, is life-threatening, requires or prolongs in-patient treatment, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'Vital signs including blood pressure, pulse rate, tympanic temperature, and respiratory rate were assessed. Number of participants with clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal 12-lead Safety Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': "ECG parameters including Ventricular rate, QRS complex of the ECG reflects the rapid depolarization of the right and left ventricles (QRS) interval, portion of the ECG between consecutive R waves, representing the ventricular rate (PR) interval, and QTc interval with Fridericia's correction method (QTcF) was measured. Number of participants with clinically significant abnormal ECG findings were reported. Clinical significance was determined by the investigator.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'Complete physical examination including general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities were performed. Number of participants with clinically significant abnormal physical examinations were reported. Clinical significance was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormal Neurological Examinations Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'Complete neurological examinations including motor system, romberg test, coordination, and direct pupillary reflexes were performed. Number of participants with clinically significant abnormal neurological examinations findings were reported. Clinical significance was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'Laboratory tests including hematology, clinical chemistry, coagulation, serology, follicle stimulating hormone (FSH) test (only for females), and urinalysis were performed. Number of participants with clinically significant changes in laboratory parameters were reported. Clinical significance was determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suicidal Ideation According to Columbia - Suicide Severity Rating Scale (C-SSRS) Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.5 months', 'description': 'The C-SSRS is a valid and reliable suicidal scale that includes a seven-item subscale that asks participants to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The suicidal ideation section is rated on a scale from 1 to 5, with higher score indicating a greater severity of suicidal ideation or risk of suicidal behavior. Participants who respond "yes" to any question related to suicidal ideation are reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of ASN51 at Each Post-dose PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 1: 0.25 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.833', 'spread': '11.839', 'groupId': 'OG000'}, {'value': '20.18', 'spread': '31.680', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 0.5 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.9', 'spread': '65.354', 'groupId': 'OG000'}, {'value': '232.7', 'spread': '228.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.8', 'spread': '28.174', 'groupId': 'OG000'}, {'value': '355.3', 'spread': '66.704', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 1.5 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.2', 'spread': '11.089', 'groupId': 'OG000'}, {'value': '311.3', 'spread': '40.934', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 2 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152.5', 'spread': '13.867', 'groupId': 'OG000'}, {'value': '310.3', 'spread': '45.559', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 3 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.2', 'spread': '11.476', 'groupId': 'OG000'}, {'value': '277.3', 'spread': '40.143', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '140.3', 'spread': '21.630', 'groupId': 'OG000'}, {'value': '281.8', 'spread': '34.032', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 6 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125.7', 'spread': '11.183', 'groupId': 'OG000'}, {'value': '254.7', 'spread': '38.568', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.8', 'spread': '7.2503', 'groupId': 'OG000'}, {'value': '244.0', 'spread': '28.071', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 12 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.30', 'spread': '8.8050', 'groupId': 'OG000'}, {'value': '199.2', 'spread': '31.212', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 16 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.98', 'spread': '4.2687', 'groupId': 'OG000'}, {'value': '154.3', 'spread': '23.036', 'groupId': 'OG001'}]}]}, {'title': 'Day 11: 8 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '326.0', 'spread': '43.253', 'groupId': 'OG000'}, {'value': '567.3', 'spread': '228.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 0.25 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '264.2', 'spread': '55.333', 'groupId': 'OG000'}, {'value': '416.2', 'spread': '175.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 0.5 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '417.8', 'spread': '130.39', 'groupId': 'OG000'}, {'value': '541.7', 'spread': '224.05', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 1 hour post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '427.8', 'spread': '54.455', 'groupId': 'OG000'}, {'value': '682.5', 'spread': '280.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 2 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '398.8', 'spread': '46.525', 'groupId': 'OG000'}, {'value': '695.3', 'spread': '285.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '362.2', 'spread': '46.357', 'groupId': 'OG000'}, {'value': '640.2', 'spread': '258.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 6 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '339.2', 'spread': '28.117', 'groupId': 'OG000'}, {'value': '599.0', 'spread': '255.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 14: 12 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '268.0', 'spread': '28.390', 'groupId': 'OG000'}, {'value': '499.2', 'spread': '214.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '242.3', 'spread': '33.279', 'groupId': 'OG000'}, {'value': '455.8', 'spread': '180.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '150.2', 'spread': '26.347', 'groupId': 'OG000'}, {'value': '295.4', 'spread': '134.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.23', 'spread': '17.151', 'groupId': 'OG000'}, {'value': '105.8', 'spread': '40.751', 'groupId': 'OG001'}]}]}, {'title': 'Day 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.52', 'spread': '22.281', 'groupId': 'OG000'}, {'value': '141.0', 'spread': '69.510', 'groupId': 'OG001'}]}]}, {'title': 'Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.38', 'spread': '15.536', 'groupId': 'OG000'}, {'value': '78.52', 'spread': '45.813', 'groupId': 'OG001'}]}]}, {'title': 'Day 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.01', 'spread': '11.685', 'groupId': 'OG000'}, {'value': '35.24', 'spread': '33.575', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours; Day 11: 8 hours; Day 14: 0.25, 0.5, 1, 2, 4, 6, 12 hours; Day 15, Day 16, Day 17, Day 18, Day 20, and Day 23', 'unitOfMeasure': 'nanograms/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included the participants who provided evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration. Number analyzed is the number of participants with data available for analysis at a specified time point.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '183', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '386', 'spread': '30.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '462', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '624', 'spread': '71.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose, and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Cmax was obtained directly from the concentration-time data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Dose-normalised Cmax (Cmax/Dose) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '18.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '19.3', 'spread': '30.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '46.2', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '71.8', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated as Cmax /Dose administered.', 'unitOfMeasure': 'ng/mL/milligram (mg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '2.05'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.767', 'groupId': 'OG000', 'lowerLimit': '0.500', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'The tmax was obtained directly from the concentration-time data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '20428', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '40365', 'spread': '56.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUCinf was calculated using the trapezoidal method for the interval 0 to tlast (time tlast is the time at which the last non-zero level was recorded), plus the area under the exponential curve from tlast to infinity.', 'unitOfMeasure': 'hours*nanograms/milliliters (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Dose-normalised AUC Infinity (AUCinf /D) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '2043', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '2018', 'spread': '56.3', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1, Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated as AUCinf /Dose administered. Here, the unit of measure is represented as hours\\*nanograms per milliliters per milligram (h\\*ng/mL/mg).', 'unitOfMeasure': 'h*ng/mL/mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '19655', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '36574', 'spread': '60.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUClast was calculated using the trapezoidal method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '2527', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '4888', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '7067', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '11237', 'spread': '73.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1, Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUCtau was calculated using the trapezoidal method.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '66.0', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'The t1/2 was calculated from the terminal slope of the log concentration-time curve as follows: t1/2 = loge 2 / lambda(λ)z.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Terminal Rate Constant (λz) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0163', 'spread': '0.00392', 'groupId': 'OG000'}, {'value': '0.0119', 'spread': '0.00444', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Terminal rate constant was estimated by linear regression of logarithmically transformed concentration versus time data.', 'unitOfMeasure': '1 per hour (1/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Clearance From Plasma After Oral Administration (CLss/F) of ASN51 at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated using the formula as follows: CLss/F = Dose/ AUCtau.', 'unitOfMeasure': 'Liters/hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution After Oral Administration (VZ/F) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.1', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '254', 'spread': '340', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated using the formula as follows: VZ/F = Dose/λz \\*AUCtau.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration (Ctrough) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Day 2', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '95.2'}, {'value': '149', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '180'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000', 'lowerLimit': '148', 'upperLimit': '201'}, {'value': '316', 'groupId': 'OG001', 'lowerLimit': '247', 'upperLimit': '404'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000', 'lowerLimit': '195', 'upperLimit': '263'}, {'value': '444', 'groupId': 'OG001', 'lowerLimit': '365', 'upperLimit': '539'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000', 'lowerLimit': '202', 'upperLimit': '279'}, {'value': '431', 'groupId': 'OG001', 'lowerLimit': '284', 'upperLimit': '654'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '280'}, {'value': '377', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '795'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '281'}, {'value': '405', 'groupId': 'OG001', 'lowerLimit': '210', 'upperLimit': '778'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Days 2, 4, 7, 11 and 14; and 8 hours post-dose on Day 11; 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14, and on Day 15', 'description': 'Trough plasma concentration i.e., measured concentration at the end of a dosing interval at steady state (taken directly before next administration, and at 1 dosing interval after the final dose) was obtained directly from the concentration-time data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio for AUC (Rac[AUC]) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '3.09'}, {'value': '2.52', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '3.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose up to Day 14', 'description': 'Accumulation ratio was calculated from area under the plasma concentration-time curve during a dosing interval at steady state, and after single dose of ASN51.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio for Cmax (Rac[Cmax]) of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'groupId': 'OG000', 'lowerLimit': '2.22', 'upperLimit': '2.88'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '1.12', 'upperLimit': '2.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose up to Day 14', 'description': 'Rac(Cmax) was calculated from Cmax at steady state and Cmax after single dose.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population included participants who had evaluable data for the comparisons of interest. These participants had at least one quantifiable plasma concentration.'}, {'type': 'SECONDARY', 'title': 'Effect of Food on PBMC Protein O-GlcNAcylation Levels During Repeated Dosing of ASN51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Predose', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '1.35'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.56', 'upperLimit': '1.97'}]}]}, {'title': '8 hours post-dose', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '1.28'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '1.34'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 8 hours post-dose on Days 11 and 14', 'description': 'The analysis of the PD response of PBMCs during repeated ASN51 dosing was conducted using ANOVA. Assessments were conducted at pre-dose and 8 hours post-dose on Day 11 (fed state) and Day 14 (fasted state). The ratio of fed to fasted has been reported.', 'unitOfMeasure': 'Ratios', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis population included all participants in the safety population for who a PBMC measure is available.'}, {'type': 'SECONDARY', 'title': 'Group 1: Estimated O-GlcNAcase Receptor Occupancy (RO) by Plasma Concentration of ASN51 and Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 1: PET Scan 2, 5.1 hours at 118.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}]}]}, {'title': 'Participant 1: PET Scan 3, 75.9 hours at 101.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2: PET Scan 2, 6.0 hours at 118.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': 'Participant 2: PET Scan 3, 196.9 hours at 4.8 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.0', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3: PET Scan 2, 5.2 hours at 121.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}]}]}, {'title': 'Participant 3: PET Scan 3, 79.3 hours at 127.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4: PET Scan 2, 5.5 hours at 171.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000'}]}]}, {'title': 'Participant 4: PET Scan 3, 77.0 hours at 91.4 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5.1, 75.9 hours post-dose on Day 1 (Participant 1); 6.0, 196.9 hours post-dose on Day 1 (Participant 2); 5.2, 79.3 hours post-dose on Day 1 (Participant 3) and 5.5 and 77.0 hours post-dose on Day 1 (Participant 4)', 'description': 'Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. Participant wise data was reported for this outcome measure.\n\nRow titles include participant number, PET scan session, post-dose time, and plasma concentration.', 'unitOfMeasure': 'percentage of receptor occupancy', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. No summary analysis was done due to low number of participants, therefore participant wise data are reported.'}, {'type': 'SECONDARY', 'title': 'Group 2: Estimated O-GlcNAcase RO by Plasma Concentration of ASN51 and Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'title': 'Participant 5: PET Scan 2, 5.5 hours at 232.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Participant 5: PET Scan 3, 75.6 hours at 67.3 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6: PET Scan 2, 5.3 hours at 309.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}, {'title': 'Participant 6: PET Scan 3, 75.4 hours at 152.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7: PET Scan 2, 4.9 hours at 267.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}, {'title': 'Participant 7: PET Scan 3, 75.9 hours at 132.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8: PET Scan 2, 5.0 hours at 304.0 ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Participant 8: PET Scan 3, 220.5 hours at 21.7ng/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5.5, 75.6 hours post-dose on Day 1 (Participant 5); 5.3, 75.4 hours post-dose on Day 1 (Participant 6); 4.9, 75.9 hours post-dose on Day 1 (Participant 7) and 5.0 and 220.5 hours post-dose on Day 1 (Participant 8)', 'description': 'Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. Participant wise data was reported for this outcome measure.\n\nRow titles include participant number, PET scan session, post-dose time, and plasma concentration.', 'unitOfMeasure': 'percentage of receptor occupancy', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan. No summary analysis was done due to low number of participants, therefore participant wise data are reported.'}, {'type': 'SECONDARY', 'title': 'Trough of [18F]-IMA601', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'OG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'timeFrame': 'Day 1 up to Day 10', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for trough volume of distribution of \\[18F\\]-IMA601 was not collected and analyzed because steady state was not achieved due to non-periodic administration before the imaging sessions.'}, {'type': 'SECONDARY', 'title': 'Receptor Occupancy as Assessed by Plasma Concentration That Corresponds to 50% Occupancy (EC50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51', 'description': 'Participants received low and high doses of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '25.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 220.5 hours post-dose on Day 1', 'description': 'Change in VT from baseline to post-dose scans were interpreted as an effect of O-GlcNAcase occupancy by ASN51. Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. The following model was fitted to the occupancy data set: Occ=100\\*Cp/Cp+EC50. Where Occ was the target occupancy (%), Cp was measured plasma concentration of ASN51 (ng/ml) and EC50 was the plasma concentration of ASN51 that corresponds to 50% occupancy. Summarized data was reported for all participants.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PET population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a PK result immediately preceding a PET scan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, once daily (QD), for 14 days in fasted or fed state.'}, {'id': 'FG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'PET Population', 'comment': 'Positron emission tomography (PET) population included all participants in the safety population who had a baseline PET scan, at least 1 post-baseline PET scan, and a pharmacokinetic (PK) result immediately preceding a PET scan.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at an investigative site in the United Kingdom from 26 January 2023 to 08 June 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'BG001', 'title': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '7.68', 'groupId': 'BG000'}, {'value': '37.3', 'spread': '6.12', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '6.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-23', 'size': 1313731, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-08T03:18', 'hasProtocol': True}, {'date': '2023-06-13', 'size': 1634447, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-08T06:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2022-12-30', 'resultsFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-07', 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Protein O-GlcNAcylation in Peripheral Blood Mononuclear Cells (PBMCs)', 'timeFrame': 'Pre-dose on Days 1, 2, 11, and 14; 8 hours post-dose on Day 1, 11 and 14; 12 hours post-dose on Day 1 and 14, 24 hours post-dose on Day 15; 72 hours post-dose on Day 17; 144 hours post-dose on Day 20', 'description': 'Protein O-GlcNAcylation in PBMCs at different time-point is reported.'}, {'measure': 'Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in frontal lobe at each brain scan was measured with a PET scan. Participants received an intravenous (IV) dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Anterior Cingulate at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in anterior cingulate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Caudate at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Caudate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Putamen at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Putamen at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan.\n\nParticipant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Accumbens at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Accumbens at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Amygdala at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in Amygdala at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}, {'measure': 'Regional VT of [18F]-IMA601 in Cerebral White Matter at Each Brain Scan', 'timeFrame': 'PET Scan 1 (Baseline), PET Scan 2 (post-dose on Day 1), PET Scan 3 (Day 4 [for participants 1, 2 (Group 2 only) 3, and 4 (Group 1 only)] and Day 9 [for participant 2 in Group 1 only] and Day 10 [for participant 4 in Group 2 only]) after final ASN51 dose', 'description': 'Regional VT of \\[18F\\]-IMA601 in cerebral white matter at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, \\[18F\\]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Up to 4.5 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with that treatment. A TEAE is defined as an AE that emerges during treatment (having been absent before treatment) or that worsens after treatment. Serious TEAE is defined as any adverse event that is fatal, is life-threatening, requires or prolongs in-patient treatment, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Vital Signs', 'timeFrame': 'Up to 4.5 months', 'description': 'Vital signs including blood pressure, pulse rate, tympanic temperature, and respiratory rate were assessed. Number of participants with clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal 12-lead Safety Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to 4.5 months', 'description': "ECG parameters including Ventricular rate, QRS complex of the ECG reflects the rapid depolarization of the right and left ventricles (QRS) interval, portion of the ECG between consecutive R waves, representing the ventricular rate (PR) interval, and QTc interval with Fridericia's correction method (QTcF) was measured. Number of participants with clinically significant abnormal ECG findings were reported. Clinical significance was determined by the investigator."}, {'measure': 'Number of Participants With Clinically Significant Abnormal Physical Examinations', 'timeFrame': 'Up to 4.5 months', 'description': 'Complete physical examination including general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities were performed. Number of participants with clinically significant abnormal physical examinations were reported. Clinical significance was determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Neurological Examinations Findings', 'timeFrame': 'Up to 4.5 months', 'description': 'Complete neurological examinations including motor system, romberg test, coordination, and direct pupillary reflexes were performed. Number of participants with clinically significant abnormal neurological examinations findings were reported. Clinical significance was determined by the investigator.'}, {'measure': 'Number of Participants With Clinically Significant Changes in Laboratory Parameters', 'timeFrame': 'Up to 4.5 months', 'description': 'Laboratory tests including hematology, clinical chemistry, coagulation, serology, follicle stimulating hormone (FSH) test (only for females), and urinalysis were performed. Number of participants with clinically significant changes in laboratory parameters were reported. Clinical significance was determined by the investigator.'}, {'measure': 'Number of Participants With Suicidal Ideation According to Columbia - Suicide Severity Rating Scale (C-SSRS) Ideation', 'timeFrame': 'Up to 4.5 months', 'description': 'The C-SSRS is a valid and reliable suicidal scale that includes a seven-item subscale that asks participants to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors. The suicidal ideation section is rated on a scale from 1 to 5, with higher score indicating a greater severity of suicidal ideation or risk of suicidal behavior. Participants who respond "yes" to any question related to suicidal ideation are reported in this outcome measure.'}, {'measure': 'Plasma Concentration of ASN51 at Each Post-dose PET Scan', 'timeFrame': 'Day 1: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours; Day 11: 8 hours; Day 14: 0.25, 0.5, 1, 2, 4, 6, 12 hours; Day 15, Day 16, Day 17, Day 18, Day 20, and Day 23'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of ASN51', 'timeFrame': 'Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose, and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Cmax was obtained directly from the concentration-time data.'}, {'measure': 'Dose-normalised Cmax (Cmax/Dose) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated as Cmax /Dose administered.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'The tmax was obtained directly from the concentration-time data.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUCinf was calculated using the trapezoidal method for the interval 0 to tlast (time tlast is the time at which the last non-zero level was recorded), plus the area under the exponential curve from tlast to infinity.'}, {'measure': 'Dose-normalised AUC Infinity (AUCinf /D) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1, Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated as AUCinf /Dose administered. Here, the unit of measure is represented as hours\\*nanograms per milliliters per milligram (h\\*ng/mL/mg).'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUClast was calculated using the trapezoidal method.'}, {'measure': 'Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1, Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'AUCtau was calculated using the trapezoidal method.'}, {'measure': 'Terminal Half-life (t1/2) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'The t1/2 was calculated from the terminal slope of the log concentration-time curve as follows: t1/2 = loge 2 / lambda(λ)z.'}, {'measure': 'Terminal Rate Constant (λz) of ASN51', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Terminal rate constant was estimated by linear regression of logarithmically transformed concentration versus time data.'}, {'measure': 'Apparent Total Clearance From Plasma After Oral Administration (CLss/F) of ASN51 at Steady State', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated using the formula as follows: CLss/F = Dose/ AUCtau.'}, {'measure': 'Apparent Volume of Distribution After Oral Administration (VZ/F) of ASN51', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14', 'description': 'Calculated using the formula as follows: VZ/F = Dose/λz \\*AUCtau.'}, {'measure': 'Trough Plasma Concentration (Ctrough) of ASN51', 'timeFrame': 'Pre-dose on Days 2, 4, 7, 11 and 14; and 8 hours post-dose on Day 11; 0.25, 0.5, 1, 2, 4, 6, and 12 hours post-dose on Day 14, and on Day 15', 'description': 'Trough plasma concentration i.e., measured concentration at the end of a dosing interval at steady state (taken directly before next administration, and at 1 dosing interval after the final dose) was obtained directly from the concentration-time data.'}, {'measure': 'Accumulation Ratio for AUC (Rac[AUC]) of ASN51', 'timeFrame': 'Pre-dose up to Day 14', 'description': 'Accumulation ratio was calculated from area under the plasma concentration-time curve during a dosing interval at steady state, and after single dose of ASN51.'}, {'measure': 'Accumulation Ratio for Cmax (Rac[Cmax]) of ASN51', 'timeFrame': 'Pre-dose up to Day 14', 'description': 'Rac(Cmax) was calculated from Cmax at steady state and Cmax after single dose.'}, {'measure': 'Effect of Food on PBMC Protein O-GlcNAcylation Levels During Repeated Dosing of ASN51', 'timeFrame': 'Predose and 8 hours post-dose on Days 11 and 14', 'description': 'The analysis of the PD response of PBMCs during repeated ASN51 dosing was conducted using ANOVA. Assessments were conducted at pre-dose and 8 hours post-dose on Day 11 (fed state) and Day 14 (fasted state). The ratio of fed to fasted has been reported.'}, {'measure': 'Group 1: Estimated O-GlcNAcase Receptor Occupancy (RO) by Plasma Concentration of ASN51 and Time', 'timeFrame': 'At 5.1, 75.9 hours post-dose on Day 1 (Participant 1); 6.0, 196.9 hours post-dose on Day 1 (Participant 2); 5.2, 79.3 hours post-dose on Day 1 (Participant 3) and 5.5 and 77.0 hours post-dose on Day 1 (Participant 4)', 'description': 'Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. Participant wise data was reported for this outcome measure.\n\nRow titles include participant number, PET scan session, post-dose time, and plasma concentration.'}, {'measure': 'Group 2: Estimated O-GlcNAcase RO by Plasma Concentration of ASN51 and Time', 'timeFrame': 'At 5.5, 75.6 hours post-dose on Day 1 (Participant 5); 5.3, 75.4 hours post-dose on Day 1 (Participant 6); 4.9, 75.9 hours post-dose on Day 1 (Participant 7) and 5.0 and 220.5 hours post-dose on Day 1 (Participant 8)', 'description': 'Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. Participant wise data was reported for this outcome measure.\n\nRow titles include participant number, PET scan session, post-dose time, and plasma concentration.'}, {'measure': 'Trough of [18F]-IMA601', 'timeFrame': 'Day 1 up to Day 10'}, {'measure': 'Receptor Occupancy as Assessed by Plasma Concentration That Corresponds to 50% Occupancy (EC50)', 'timeFrame': 'Up to 220.5 hours post-dose on Day 1', 'description': 'Change in VT from baseline to post-dose scans were interpreted as an effect of O-GlcNAcase occupancy by ASN51. Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. The following model was fitted to the occupancy data set: Occ=100\\*Cp/Cp+EC50. Where Occ was the target occupancy (%), Cp was measured plasma concentration of ASN51 (ng/ml) and EC50 was the plasma concentration of ASN51 that corresponds to 50% occupancy. Summarized data was reported for all participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a phase 1, open-label, dose escalation, positron emission tomography (PET) study to investigate the brain occupancy of O-GlcNAcase, and the pharmacodynamics (PD) response in peripheral blood mononuclear cells (PBMCs), after repeated doses of ASN51 in healthy participants.', 'detailedDescription': 'The clinical data from the first-in-human single- and multiple-ascending dose study of ASN51 (ASN51-101), and the adaptive-design PET study of O-GlcNAcase brain ASN51 occupancy after single oral doses (ASN51-102), showed acceptable safety, tolerability and pharmacokinetics (PK). However, to date, no assessment of receptor occupancy (RO) after multiple doses of ASN51 and at plasma concentrations below the EC50 have been done. Hence, the purpose of this study is to assess brain O-GlcNAcase RO using PET following repeated doses of ASN51. The study will also characterise the PBMC response (including the effect of food), and further assess the safety, tolerability, PK, and PK/RO relationship, after repeated ASN51 doses.\n\nThe results of this study will be used to select doses for subsequent studies in participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Normotensive male volunteer (PET participants).\n2. Male or female volunteer of non-childbearing potential (PBMC-only participants).\n3. Deemed healthy on the basis of a clinical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine.\n4. Agree to follow the contraception requirements of the trial.\n5. Able to give fully informed written consent.\n\nExclusion Criteria:\n\n1. Significant (\\> 10%) recent weight change.\n2. Positive tests for hepatitis B and hepatitis C, human immunodeficiency virus (HIV).\n3. Severe adverse reaction to any drug.\n4. Sensitivity to trial medication.\n5. Drug or alcohol abuse.\n6. Regular consumption of xanthine-containing products.\n7. Frequent use of nicotine-containing products.\n8. Severe adverse reaction to any drug.\n9. Sensitivity to trial medication (all participants) or PET imaging radioligand (PET participants).\n10. Use of over-the-counter medication (with the exception of paracetamol \\[acetaminophen\\]) during the 7 days before the first dose of radioligand (PET participants) or trial medication (PBMC participants) (or longer if the medicine is a potential enzyme inducer), or prescribed medication during the 28 days before first dose of radioligand (PET participants) or trial medication (PBMC participants).\n11. Received vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 2 weeks of screening.\n12. Participation in other clinical trials of unlicensed medicines.\n13. Loss of more than 400 milliliters (mL) blood, within the 3 months before the first dose of tracer (PET participants) or trial medication (PBMC participants).\n14. Clinically relevant abnormal findings at the screening assessment, including ECG abnormalities (all participants) or those identified by MRI scan (PET participants only).\n15. Acute or chronic illness.\n16. Clinically relevant abnormal history of or concurrent medical (including neurological or psychiatric) condition.\n17. Positive columbia-suicide severity rating scale (C-SSRS) result.\n18. Vegan.\n19. Possibility that volunteer will not cooperate.\n20. Unsatisfactory venous access.\n21. Objection by general practitioner (GP).\n22. PET participants only: significant exposure to research related radiation (more than 10 millisievert \\[mSv\\]) within the previous 12 months.\n23. Contraindications to arterial cannulation (e.g., allen's test indicates risk) or magnetic resonance imaging (MRI) scanning (e.g., presence of a cardiac pacemaker or other implanted electronic device or a history of claustrophobia)."}, 'identificationModule': {'nctId': 'NCT05725005', 'briefTitle': 'PET Study of Repeated ASN51 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asceneuron S.A.'}, 'officialTitle': 'A Phase 1, Open-label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Target Occupancy of ASN51 Following Repeated Oral Doses', 'orgStudyIdInfo': {'id': 'ASN51-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ASN51 Low Dose', 'description': 'Participants received low dose of ASN51, orally, once-daily (QD) for 14 days in fasted or fed state.', 'interventionNames': ['Drug: ASN51']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: ASN51 High Dose', 'description': 'Participants received high dose of ASN51, orally, QD for 14 days in fasted or fed state.', 'interventionNames': ['Drug: ASN51']}], 'interventions': [{'name': 'ASN51', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Group 1: ASN51 Low Dose', 'Group 2: ASN51 High Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Adeep Puri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammersmith Medicines Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asceneuron S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hammersmith Medicines Research', 'class': 'OTHER'}, {'name': 'Invicro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}