Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03717558
Status:
WITHDRAWN
Last Update Posted:
2018-10-24
First Post:
2018-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability Pilot Study of Versus W0035 Versus Stromectol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open label, crossover, randomized, 5-period, 20-sequence, partial replicate, single dose design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of ivermectin', 'timeFrame': '5 periods of 3 days each', 'description': 'At each period: 17 blood samples: T0 (Pre-dose), T0 +15min, T0 +30min, T0 +1h, T0+1h30min, T0 +2h, T0 +2h30, T0 +3h, T0 +3h30, T0 +4h, T0 +4h30, T0 +5h, T0 +6h, T0 +12h, T0 +24h, T0 +48h and T0 +72h'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Ivermectin is prescribed for the treatment of helminthic infections sensitive to ivermectin. However, it is currently only available as a tablet formulation. W0035 is a powder for oral suspension of ivermectin developed by PIERRE FABRE DERMATOLOGIE intended to be administered to children for the treatment of helminthic infections sensitive to ivermectin and mentioned in the Summary of Product Characteristics (SmPC) of Stromectol.\n\nPIERRE FABRE DERMATOLOGIE intends to carry out this pilot bioavailability study in order to define the most appropriate formulation to be used in the bioequivalence study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18.5 ≤ BMI ≤ 30.0 kg/m².\n* Non-smoker subject with a breath carbon monoxide reading of ≤10 ppm at screening.\n* Agree to use effective contraception method\n\nExclusion Criteria: most specific out of 30.\n\n* History of or current symptomatic orthostatic hypotension\n* Hyper-eosinophilia or subject at risk of microfilaremic disease or clinical suspicion of intestinal helminth infection\n* History of or current macroscopic or microscopic hematuria\n* Positive serology for Hepatitis Bs antigen (HBs), Hepatitis C Virus (HCV) and HIV 1 and 2 antibodies.\n* Organic disorder likely to modify, absorption, distribution or elimination of the medication.'}, 'identificationModule': {'nctId': 'NCT03717558', 'briefTitle': 'Bioavailability Pilot Study of Versus W0035 Versus Stromectol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Dermatology'}, 'officialTitle': 'Comparative Bioavailability Pilot Study of 3 W0035 Test Oral Suspensions (Ivermectin 1mg/mL) Versus Stromectol® (Ivermectin, 3 mg Tablet) After Single Oral Administration in Healthy Volunteers. Single Centre, Open Label, Crossover, Randomized, 5-period, 20-sequence, Partial Replicate, Single Dose Design', 'orgStudyIdInfo': {'id': 'W00035 PU 1 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stromectol R', 'description': 'Stromectol R = ivermectin 3mg (tablet)', 'interventionNames': ['Drug: ivermectin T1', 'Drug: ivermectin T2', 'Drug: ivermectin T3']}, {'type': 'EXPERIMENTAL', 'label': 'ivermectin T1', 'description': 'T1= ivermectin low grade particle Size Distribution', 'interventionNames': ['Drug: ivermectin T1', 'Drug: ivermectin T2', 'Drug: ivermectin T3']}, {'type': 'EXPERIMENTAL', 'label': 'ivermectin T2', 'description': 'T2= ivermectin medium grade particle Size Distribution', 'interventionNames': ['Drug: ivermectin T1', 'Drug: ivermectin T2', 'Drug: ivermectin T3']}, {'type': 'EXPERIMENTAL', 'label': 'ivermectin T3', 'description': 'T= ivermectin high grade particle Size Distribution', 'interventionNames': ['Drug: ivermectin T1', 'Drug: ivermectin T2', 'Drug: ivermectin T3']}], 'interventions': [{'name': 'ivermectin T1', 'type': 'DRUG', 'description': 'Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol', 'armGroupLabels': ['Stromectol R', 'ivermectin T1', 'ivermectin T2', 'ivermectin T3']}, {'name': 'ivermectin T2', 'type': 'DRUG', 'description': 'Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol', 'armGroupLabels': ['Stromectol R', 'ivermectin T1', 'ivermectin T2', 'ivermectin T3']}, {'name': 'ivermectin T3', 'type': 'DRUG', 'description': 'Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol', 'armGroupLabels': ['Stromectol R', 'ivermectin T1', 'ivermectin T2', 'ivermectin T3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Karim Keddad, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut de Recherche Pierre Fabre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Dermatology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}