Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04347005
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2020-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}, {'id': 'D000069465', 'term': 'Febuxostat'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings', 'timeFrame': '8 Days', 'description': 'Analysis of abnormal safety laboratory findings'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG Heart Rate'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG PR-Interval'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG RR-Interval'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG QRS-Interval'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG QT-Interval'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'ECG QTc-Interval'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'Vital Sign - Systolic Blood Pressure'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'Vital Sign - Diastolic Blood Pressure'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'Vital Sign - Pulse Rate'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'Vital Sign - Body Temperature'}, {'measure': 'Safety Analyses', 'timeFrame': '8 Days', 'description': 'Vital Sign - Respiratory Rate'}, {'measure': 'Area under the curve (AUC) for plasma AR882', 'timeFrame': '6 Days', 'description': 'Profile from plasma in terms of AUC for AR882'}, {'measure': 'Time to maximum plasma concentration (Tmax) for AR882', 'timeFrame': '6 Days', 'description': 'Profile from plasma in terms of Tmax for AR882'}, {'measure': 'Maximum plasma concentration (Cmax) for AR882', 'timeFrame': '6 Days', 'description': 'Profile from plasma in terms of Cmax for AR882'}, {'measure': 'Apparent terminal half-life (t1/2) for AR882', 'timeFrame': '6 Days', 'description': 'Profile from plasma in terms of t1/2 for AR882'}, {'measure': 'Amount excreted (Ae) into urine for AR882', 'timeFrame': '6 Days', 'description': 'Profile from urine in terms of Ae for AR882'}, {'measure': 'Fractional Excretion (FEUA) for AR882', 'timeFrame': '6 Days', 'description': 'Profile from urine in terms of FEUA for AR882'}], 'secondaryOutcomes': [{'measure': 'PD profile of a single dose of AR882', 'timeFrame': '6 Days', 'description': 'Profile from serum uric acid concentrations over time'}, {'measure': 'PD profile of a single dose of AR882 in combination with allopurinol', 'timeFrame': '6 Days', 'description': 'Profile from serum uric acid concentrations over time'}, {'measure': 'PD profile of a single dose of AR882 in combination with febuxostat', 'timeFrame': '6 Days', 'description': 'Profile from serum uric acid concentrations over time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)\n* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2\n* Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures\n\nExclusion Criteria:\n\n* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin\n* History of cardiac abnormalities\n* History and/or presence of drug addiction or excessive use of alcohol"}, 'identificationModule': {'nctId': 'NCT04347005', 'briefTitle': 'The Study is Designed to Evaluate Single Ascending Doses of AR882 in Healthy Adult Males', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthrosi Therapeutics'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers', 'orgStudyIdInfo': {'id': 'AR882-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose A)', 'interventionNames': ['Drug: Cohort 1: AR882']}, {'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose B)', 'interventionNames': ['Drug: Cohort 2: AR882', 'Drug: Cohort 6: AR882 Food Effect', 'Drug: Cohort 8: AR882 in combination with allopurinol', 'Drug: Cohort 9: AR882 in combination with febuxostat']}, {'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose C)', 'interventionNames': ['Drug: Cohort 3: AR882']}, {'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose D)', 'interventionNames': ['Drug: Cohort 4: AR882']}, {'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose E)', 'interventionNames': ['Drug: Cohort 5: AR882']}, {'type': 'EXPERIMENTAL', 'label': 'AR882 (Dose B) Solid Oral Formulation', 'interventionNames': ['Drug: Cohort 7: AR882 Solid Oral Formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Cohort 1: AR882', 'Drug: Cohort 2: AR882', 'Drug: Cohort 3: AR882', 'Drug: Cohort 4: AR882', 'Drug: Cohort 5: AR882', 'Drug: Cohort 6: AR882 Food Effect', 'Drug: Cohort 7: AR882 Solid Oral Formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol', 'interventionNames': ['Drug: Cohort 8: AR882 in combination with allopurinol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Febuxostat', 'interventionNames': ['Drug: Cohort 9: AR882 in combination with febuxostat']}], 'interventions': [{'name': 'Cohort 1: AR882', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose A)', 'Placebo']}, {'name': 'Cohort 2: AR882', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose B)', 'Placebo']}, {'name': 'Cohort 3: AR882', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose C)', 'Placebo']}, {'name': 'Cohort 4: AR882', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose D)', 'Placebo']}, {'name': 'Cohort 5: AR882', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose E)', 'Placebo']}, {'name': 'Cohort 6: AR882 Food Effect', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo in a fed state', 'armGroupLabels': ['AR882 (Dose B)', 'Placebo']}, {'name': 'Cohort 7: AR882 Solid Oral Formulation', 'type': 'DRUG', 'description': 'Single dose of AR882 or matching placebo', 'armGroupLabels': ['AR882 (Dose B) Solid Oral Formulation', 'Placebo']}, {'name': 'Cohort 8: AR882 in combination with allopurinol', 'type': 'DRUG', 'description': 'Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol', 'armGroupLabels': ['AR882 (Dose B)', 'Allopurinol']}, {'name': 'Cohort 9: AR882 in combination with febuxostat', 'type': 'DRUG', 'description': 'Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat', 'armGroupLabels': ['AR882 (Dose B)', 'Febuxostat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network Pty, Ltd.', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthrosi Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}