Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 6:59 AM
Study NCT ID:
NCT01765933
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Effects of Oral DMAA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031563', 'term': '17-N,N-diethylcarbamoyl-4-methyl-4-azaandrostane-3-one'}, {'id': 'C571979', 'term': '1,3-dimethylamylamine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-08', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cutaneous temperature', 'timeFrame': '0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr', 'description': 'skin temperature'}], 'primaryOutcomes': [{'measure': 'pharmacokinetics', 'timeFrame': '0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr', 'description': 'The area under the plasma concentration-time curve from time 0 to infinity was calculated using the trapezoidal rule extrapolated to time infinity. The terminal half-life (t 1/2) was calculated using 0.693/Lambda z, with Lambda z as the terminal rate elimination constant. Peak concentration (Cmax), lag time (tlag), time of maximum concentration (tmax), apparent volume of distribution during the terminal elimination phase (Vz/F), and oral clearance (CL/F) were also calculated.'}], 'secondaryOutcomes': [{'measure': 'physiological effects on heart rate and blood pressure', 'timeFrame': '0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hr', 'description': 'heart rate, blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['1,3-dimethylamylamine'], 'conditions': ['Outcomes of Single Oral Dose']}, 'referencesModule': {'references': [{'pmid': '24090077', 'type': 'DERIVED', 'citation': 'Schilling BK, Hammond KG, Bloomer RJ, Presley CS, Yates CR. Physiological and pharmacokinetic effects of oral 1,3-dimethylamylamine administration in men. BMC Pharmacol Toxicol. 2013 Oct 4;14:52. doi: 10.1186/2050-6511-14-52.'}]}, 'descriptionModule': {'briefSummary': '1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary supplements. It is also used within "party pills," often in conjunction with alcohol and other drugs, and has been associated with untoward effects when abused at high dosages. To our knowledge, no studies have been conducted to determine the combined pharmacokinetic profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based solely on case reports would be problematic, in particular when accepting testimony from patients in uncontrolled environment, potentially under the influence of alcohol and other drugs. This is especially true in light of the fact that no prospective studies have shown these effects. Hence, the intent of the present study was to determine the pharmacokinetic profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This represents a typical dosage within one serving of many popular dietary supplements containing DMAA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be able to swallow pill\n\nExclusion Criteria:\n\n* self-reported cardiovascular or metabolic problems\n* current smokers'}, 'identificationModule': {'nctId': 'NCT01765933', 'briefTitle': 'Pharmacokinetic Effects of Oral DMAA', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'Pharmacokinetic and Physiological Effects of Oral DMAA Administration', 'orgStudyIdInfo': {'id': 'DMAA Pharmacokinetics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DMAA', 'description': 'Single oral dose 25 mg DMAA', 'interventionNames': ['Dietary Supplement: DMAA']}], 'interventions': [{'name': 'DMAA', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['1,3-dimethylamylamine'], 'description': 'no placebo', 'armGroupLabels': ['DMAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38152', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The University of Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tennessee', 'class': 'OTHER'}, {'name': 'USP Labs, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brian Schilling', 'investigatorAffiliation': 'University of Memphis'}}}}