Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-29 @ 10:07 AM
Study NCT ID:
NCT05032833
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008732', 'term': 'Methoxydimethyltryptamines'}], 'ancestors': [{'id': 'D004130', 'term': 'N,N-Dimethyltryptamine'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002027', 'term': 'Bufotenin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012701', 'term': 'Serotonin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with treatment emergent AEs (TEAES)', 'timeFrame': 'From screening through to the follow up visit, up to 65 days'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'Day 1 (dosing day) and Day 2'}, {'measure': 'Time to reach Cmax (tmax)', 'timeFrame': 'Day 1 (dosing day) and Day 2'}, {'measure': 'Area under the plasma concentration- time curve', 'timeFrame': 'Day 1 (dosing day) and Day 2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics in Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Medically healthy based on medical records and study specific assessments\n\nExclusion Criteria:\n\n\\* Presence or history of severe adverse reaction to any drug or drug excipient'}, 'identificationModule': {'nctId': 'NCT05032833', 'briefTitle': 'Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beckley Psytech Limited'}, 'officialTitle': 'A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BPL-5MEO-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-MeO-DMT arm', 'interventionNames': ['Drug: 5-MeO-DMT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '5-MeO-DMT', 'type': 'DRUG', 'description': 'A single dose of 5-MeO-DMT will be administered intranasally', 'armGroupLabels': ['5-MeO-DMT arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A single dose of placebo will be administered intranasally', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beckley Psytech Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}