Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT02322957
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526677', 'term': 'FV-100'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of safety of a single oral dose of FV-100 alone and when combined with a single oral dose of ritonavir', 'timeFrame': 'Two weeks', 'description': 'Measuring the Cmax, Tmax and AUC for FV-100 pk profile'}, {'measure': 'The evaluation of the pharmacokinetics of FV-100 and CF-1743 following a single oral dose of FV-100 administered alone and with a single oral dose of ritonavir', 'timeFrame': 'Two weeks', 'description': 'Measuring the Cmax, Tmax and AUC for FV-100 pk profile when dosed with ritonavir'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Herpes Zoster']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the potential for a PK drug-drug interaction between FV-100 and ritonavir. The study is a single-center, open-label, randomized, 2-way crossover design in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of giving written informed consent\n* Non-tobacco user for at least 3 months prior to selection\n* Healthy on the basis of physical examination, medical history, ECG and clinical laboratory testing at screening\n\nExclusion Criteria:(must NOT meet the following)\n\n* Infected with Hepatitis A, B, C, or HIV\n* History of or any current medical condition which could impact safety of the participant\n* A positive urine drug test\n* Consumption of more than 2 units of alcoholic beverages per day or more than 14 per week\n* Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half-lives before the planned start of treatment or prior treatment with FV-100\n* Subjects who have used any drugs or substances known to inhibit or induce cytochrome(CYP) P450 enzymes and/or P-gp within 28 days prior to the first dose and throughout study\n* Subjects who have, within 2 weeks prior to the first dose of study drug, ingested grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family or charbroiled meats'}, 'identificationModule': {'nctId': 'NCT02322957', 'briefTitle': 'A Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers', 'organization': {'class': 'UNKNOWN', 'fullName': 'ContraVir'}, 'officialTitle': 'A Phase 1 Study Investigating the Pharmacokinetics of FV-100 With and Without Ritonavir in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CTRV-FV-1-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Regimen A', 'description': 'FV-100 400mg OD as a single dose fasted (\\>/= 8 hours)', 'interventionNames': ['Drug: FV-100']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Regimen B', 'description': 'FV-100 400 mg OD as a single dose with ritonavir 200mg OD as a single fasted dose (\\>/= 8 hours)', 'interventionNames': ['Drug: FV-100']}], 'interventions': [{'name': 'FV-100', 'type': 'DRUG', 'description': 'Subjects will be randomized to one of two treatment sequences: AB or BA.', 'armGroupLabels': ['Treatment Regimen A', 'Treatment Regimen B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ContraVir Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}