Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT03459794
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ivermectin and Human Immunity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adrianw@uga.edu', 'phone': '706 542 2404', 'title': 'Dr Adrian Wolstenholme', 'organization': 'University of Georgia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day following administration of the drug/placebo', 'eventGroups': [{'id': 'EG000', 'title': 'Ivermectin', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor gastrointestinal upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'units': 'Cytokines', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin 4hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment'}, {'id': 'OG001', 'title': 'Ivermectin 24 Hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment'}, {'id': 'OG002', 'title': 'Control 4 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment'}, {'id': 'OG003', 'title': 'Control 24 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.'}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment, 4 hours and 24 hours post-treatment', 'description': 'Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=\\<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.', 'unitOfMeasure': 'Cytokines changed from t=0', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cytokines', 'denomUnitsSelected': 'Cytokines', 'populationDescription': 'Cytokines were measured in sera using the HCYTOMAG-60K-PX41 kit from EMD Millipore. The numbers reported are the number of cytokines with statistically significant changes ( p = \\<0.05) from pre-treatment levels.'}, {'type': 'PRIMARY', 'title': 'Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin 4hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth. 4 hrs post-treatment'}, {'id': 'OG001', 'title': 'Ivermectin 24 Hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.24 hrs post-treatment'}, {'id': 'OG002', 'title': 'Control 4 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Sera collected 4hrs post-treatment'}, {'id': 'OG003', 'title': 'Control 24 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Sera collected 24hrs post-treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\\<0.05.'}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment, 4 hours and 24 hours post-treatment', 'description': 'Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.', 'unitOfMeasure': 'Transcripts signicantly changed from t=0', 'reportingStatus': 'POSTED', 'populationDescription': 'Levels of 770 messenger RNAs (mRNAs) were assayed in PBMC isolated from study participants using the Human Nanostring Myeloid cell panel.'}, {'type': 'SECONDARY', 'title': 'Complete Blood Counts (CBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin 0 Hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth. Blood collected at t=0'}, {'id': 'OG001', 'title': 'Ivermectin 24 Hrs', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.Blood collected 24 hrs post-treatment'}, {'id': 'OG002', 'title': 'Control 0 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Blood collected at t=0'}, {'id': 'OG003', 'title': 'Control 24 Hrs', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once. Blood collected 24hrs post-treatment'}], 'classes': [{'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '3.069', 'spread': '0.353', 'groupId': 'OG000'}, {'value': '3.341', 'spread': '0.426', 'groupId': 'OG001'}, {'value': '2.940', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '3.358', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '1.753', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.864', 'spread': '0.151', 'groupId': 'OG001'}, {'value': '1.833', 'spread': '0.161', 'groupId': 'OG002'}, {'value': '2.075', 'spread': '0.175', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.483', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.403', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '0.373', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.375', 'spread': '0.034', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '0.208', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.205', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '0.158', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.170', 'spread': '0.018', 'groupId': 'OG003'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.008', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '0.048', 'spread': '0.008', 'groupId': 'OG002'}, {'value': '0.048', 'spread': '0.0005', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment (0hrs), 24 hours', 'description': 'CBCs will be performed before treatment and 24 hrs later', 'unitOfMeasure': 'Million cells/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ivermectin', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.'}, {'id': 'FG001', 'title': 'Control', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ivermectin', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.\n\nIvermectin: 150 mcg/kg ivermectin, by mouth.'}, {'id': 'BG001', 'title': 'Control', 'description': 'An oral placebo will be administered once\n\nPlacebo: An oral placebo will be administered, once'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-27', 'size': 802967, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-11-28T09:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2018-02-22', 'resultsFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-26', 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.', 'timeFrame': 'Pre-treatment, 4 hours and 24 hours post-treatment', 'description': 'Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=\\<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.'}, {'measure': 'Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.', 'timeFrame': 'Pre-treatment, 4 hours and 24 hours post-treatment', 'description': 'Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.'}], 'secondaryOutcomes': [{'measure': 'Complete Blood Counts (CBC)', 'timeFrame': 'Pre-treatment (0hrs), 24 hours', 'description': 'CBCs will be performed before treatment and 24 hrs later'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ivermectin']}, 'referencesModule': {'references': [{'pmid': '34090504', 'type': 'DERIVED', 'citation': 'Wilson NE, Reaves BJ, Wolstenholme AJ. Lack of detectable short-term effects of a single dose of ivermectin on the human immune system. Parasit Vectors. 2021 Jun 5;14(1):304. doi: 10.1186/s13071-021-04810-6.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare the cell types present in the blood and the chemicals known to influence the human immune system before and after the drug is given, as well as measuring any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.', 'detailedDescription': 'Subjects will visit the University of Georgia (UGA) Clinical \\& Translation Research Unit (CTRU) twice on consecutive days and blood will be drawn from them. On the first occasion they will be weighed and will complete the consent process. They will have been randomly assigned to the test (Stromectol) or control (placebo) group, with 8 participants in the test group and 4 participants in the control group. Stromectol will be obtained from a medical supply distributor and a placebo will be obtained through the UGA School of Pharmacy. Drugs will be prescribed by Jonathan Murrow MD. They will be stored in their original packaging at room temperature in a drug locker in the lab at CTRU. Participants will be identified by number and allocated to groups using a block randomization protocol. Randomization and drug dispensation will be done by CTRU. Eighteen ml of blood will drawn in a fasting state and they will be administered 150 mcg/kg Stromectol or the equivalent number of placebo tablets immediately after blood is drawn. Participants will remain at CTRU for four hours after they take the drug, then another 15ml of blood will be drawn. On the second day they will attend CTRU at the same time and the third blood sample will be drawn 24 hrs after administration of the drug. On each occasion the drawn blood will be coded by CTRU staff prior to being collected by a member of the Department of Infectious Diseases and taken to the laboratory (Wildlife Health G0007) for the isolation of leukocyte populations (peripheral monocytes, lymphocytes and polymorphonuclear cells (PMNs)) and for the preparation of serum. Complete blood counts will also be carried out. Sera will be analyzed on the Luminex for cytokine/chemokine content. RNA will be isolated from the cell populations for RNASeq analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight over 110 pounds and under 185 pounds\n\nExclusion Criteria:\n\n* Pregnancy or nursing mothers.\n* Immunosuppressed individuals.\n* Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).\n* Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present\n* Hepatitis/HIV\n* Currently taking warfarin\n* Lactose intolerance (Lactose present in placebo)\n* Currently taking Steroid medications (inhaled, oral or injection)\n* Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)\n* Liver or renal dysfunction'}, 'identificationModule': {'nctId': 'NCT03459794', 'briefTitle': 'Ivermectin and Human Immunity', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'The Effects of Ivermectin on Human Innate Immunity Against Filarial Parasites', 'orgStudyIdInfo': {'id': 'STUDY00005069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivermectin', 'description': 'Ivermectin will be administered once at 150mcg/kg, orally.', 'interventionNames': ['Drug: Ivermectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'An oral placebo will be administered once', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ivermectin', 'type': 'DRUG', 'description': '150 mcg/kg ivermectin, by mouth.', 'armGroupLabels': ['Ivermectin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'An oral placebo will be administered, once', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Adrian J Wolstenholme, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adrian Wolstenholme', 'investigatorAffiliation': 'University of Georgia'}}}}