Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05698095
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008732', 'term': 'Methoxydimethyltryptamines'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study will include separate single- and multiple-dose parts.\n\nSingle-dose part:\n\nA double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in 6 cohorts of 6 subjects (randomized as 5 active and 1 placebo subject(s) per group).\n\nMultiple-dose part:\n\nA double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in up to two doses within a single day (3-hour interval) with two different dose levels (6 subjects per group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-01-05', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0', 'timeFrame': 'Up to 30 Days', 'description': 'Number of participants with TEAEs following administration of 5-MeO-DMT.'}], 'secondaryOutcomes': [{'measure': 'Plasma pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT', 'timeFrame': 'Up to 24 hours', 'description': 'For PK analysis, blood samples will be collected before and up to 24 hours after the intramuscular administration of 5-MeO-DMT to determine 5-MeO-DMT and bufotenine serum concentrations.'}, {'measure': 'Urine pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT', 'timeFrame': 'Up to 24 hours', 'description': 'For PK analysis, urine samples will be collected before and up to 24 hours after the intramuscular administration of 5-MeO-DMT to determine 5-MeO-DMT and bufotenine urine concentrations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['5-MeO-DMT', 'Psychedelics', 'Safety', 'Pharmacokinetics', 'First-in-human', '5-methoxy-N,N-dimethyltryptamine'], 'conditions': ['Pharmacokinetics', 'Safety', 'Tolerability']}, 'referencesModule': {'references': [{'pmid': '34912222', 'type': 'BACKGROUND', 'citation': 'Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021.'}, {'pmid': '20942780', 'type': 'BACKGROUND', 'citation': 'Shen HW, Jiang XL, Winter JC, Yu AM. Psychedelic 5-methoxy-N,N-dimethyltryptamine: metabolism, pharmacokinetics, drug interactions, and pharmacological actions. Curr Drug Metab. 2010 Oct;11(8):659-66. doi: 10.2174/138920010794233495.'}, {'pmid': '30574112', 'type': 'BACKGROUND', 'citation': 'Barsuglia J, Davis AK, Palmer R, Lancelotta R, Windham-Herman AM, Peterson K, Polanco M, Grant R, Griffiths RR. Intensity of Mystical Experiences Occasioned by 5-MeO-DMT and Comparison With a Prior Psilocybin Study. Front Psychol. 2018 Dec 6;9:2459. doi: 10.3389/fpsyg.2018.02459. eCollection 2018.'}, {'pmid': '29708042', 'type': 'BACKGROUND', 'citation': 'Davis AK, Barsuglia JP, Lancelotta R, Grant RM, Renn E. The epidemiology of 5-methoxy- N, N-dimethyltryptamine (5-MeO-DMT) use: Benefits, consequences, patterns of use, subjective effects, and reasons for consumption. J Psychopharmacol. 2018 Jul;32(7):779-792. doi: 10.1177/0269881118769063. Epub 2018 Apr 30.'}, {'pmid': '34666554', 'type': 'BACKGROUND', 'citation': 'Ermakova AO, Dunbar F, Rucker J, Johnson MW. A narrative synthesis of research with 5-MeO-DMT. J Psychopharmacol. 2022 Mar;36(3):273-294. doi: 10.1177/02698811211050543. Epub 2021 Oct 19.'}, {'pmid': '30982127', 'type': 'BACKGROUND', 'citation': 'Uthaug MV, Lancelotta R, van Oorsouw K, Kuypers KPC, Mason N, Rak J, Sulakova A, Jurok R, Maryska M, Kuchar M, Palenicek T, Riba J, Ramaekers JG. A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Psychopharmacology (Berl). 2019 Sep;236(9):2653-2666. doi: 10.1007/s00213-019-05236-w. Epub 2019 Apr 13.'}, {'pmid': '33344861', 'type': 'BACKGROUND', 'citation': 'Sherwood AM, Claveau R, Lancelotta R, Kaylo KW, Lenoch K. Synthesis and Characterization of 5-MeO-DMT Succinate for Clinical Use. ACS Omega. 2020 Dec 2;5(49):32067-32075. doi: 10.1021/acsomega.0c05099. eCollection 2020 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.', 'detailedDescription': 'This study is a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single-dose and multiple-ascending-dose study of 5-MeO-DMT administered by intramuscular injection in 54 healthy subjects (adult male and/or females, 18-65 years of age). Subjects will be randomized 6:1 to receive 5-MeO-DMT or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult male or female.\n* Aged at least 18 years but not older than 65 years, inclusive.\n* Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive.\n\nExclusion Criteria:\n\n* History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee).\n* Participants who, in the opinion of the investigator (or designee), should not participate in this study.\n* Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.'}, 'identificationModule': {'nctId': 'NCT05698095', 'briefTitle': 'Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Usona Institute'}, 'officialTitle': 'A Phase 1, First-in-human, Double-blind, Placebo-controlled, Randomized, Single- and Multiple-ascending-dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Administered by Intramuscular Injection in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MEO101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - 0.5 mg single-dose', 'description': 'A single 0.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - 2.5 mg single-dose', 'description': 'A single 2.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - 4.5 mg single-dose', 'description': 'A single 4.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 - 7 mg single-dose', 'description': 'A single 7 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5 - 10 mg single-dose', 'description': 'A single 10 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6 - 13 mg single-dose', 'description': 'A single 5-MeO-DMT 13 mg or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 7 - multiple-dose, 3 hour interval', 'description': 'Administration of up to two 5-MeO-DMT (2.5 mg followed by 4.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 8 - multiple-dose, 3 hour interval', 'description': 'Administration of up to two 5-MeO-DMT (2.5 mg followed by 7 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 9 - multiple-dose, 3 hour interval', 'description': 'Administration of up to two 5-MeO-DMT (2.5 mg followed by 10.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).', 'interventionNames': ['Drug: 5-methoxy-N,N-dimethyltryptamine succinate salt', 'Drug: Placebo']}], 'interventions': [{'name': '5-methoxy-N,N-dimethyltryptamine succinate salt', 'type': 'DRUG', 'otherNames': ['5-MeO-DMT succinate salt', '5-MeO-DMT'], 'description': 'The 5-MeO-DMT drug product is comprised of the appropriate concentration of 5-MeO-DMT succinate salt drug substance in solution with 0.9% sodium chloride injection solution (USP) in a 5 mL glass vial, and is administered intramuscularly.', 'armGroupLabels': ['Cohort 1 - 0.5 mg single-dose', 'Cohort 2 - 2.5 mg single-dose', 'Cohort 3 - 4.5 mg single-dose', 'Cohort 4 - 7 mg single-dose', 'Cohort 5 - 10 mg single-dose', 'Cohort 6 - 13 mg single-dose', 'Cohort 7 - multiple-dose, 3 hour interval', 'Cohort 8 - multiple-dose, 3 hour interval', 'Cohort 9 - multiple-dose, 3 hour interval']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride solution (USP)'], 'description': 'The placebo is commercially available 0.9% sodium chloride solution (USP) for injection. The placebo is provided by the pharmacy in single-use sterile syringes of the appropriate dose.', 'armGroupLabels': ['Cohort 1 - 0.5 mg single-dose', 'Cohort 2 - 2.5 mg single-dose', 'Cohort 3 - 4.5 mg single-dose', 'Cohort 4 - 7 mg single-dose', 'Cohort 5 - 10 mg single-dose', 'Cohort 6 - 13 mg single-dose', 'Cohort 7 - multiple-dose, 3 hour interval', 'Cohort 8 - multiple-dose, 3 hour interval', 'Cohort 9 - multiple-dose, 3 hour interval']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Altasciences Clinical Kansas, Inc', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Usona Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}