Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT06379958
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D010672', 'term': 'Phenytoin'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'C000613732', 'term': 'upadacitinib'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leramistat: Area under the curve - AUC0-t', 'timeFrame': '8.5 Weeks'}, {'measure': 'leramistat: Area under the curve - AUC0-24h', 'timeFrame': '8.5 Weeks'}, {'measure': 'leramistat: Area under the curve - AUC0-inf', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat: Maximum observed concentration - Cmax', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat: Time of the maximum observed concentration - Tmax', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat:Elimination rate constant -Kel', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat: Half life - t½', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat: Plasma Clearance -CL/F', 'timeFrame': '8.5 weeks'}, {'measure': 'leramistat: Volume of distribution - Vz/F', 'timeFrame': '8.5 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse event.', 'timeFrame': '8.5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Principal Inclusion Criteria:\n\nHealthy, adult, male or female of non childbearing potential 18 to 55 years of age.\n\nPrincipal Exclusion Criteria:\n\nHistory or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n\nHistory of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.'}, 'identificationModule': {'nctId': 'NCT06379958', 'briefTitle': 'Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Modern Biosciences Ltd'}, 'officialTitle': 'A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'IST-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part 1: Itraconazole 200mg', 'interventionNames': ['Drug: leramistat 40mg', 'Drug: Itraconazole 200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Phenytoin 100mg', 'interventionNames': ['Drug: leramistat 40mg', 'Drug: Phenytoin 100 Mg Oral Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 3: Simvastatin 40mg', 'interventionNames': ['Drug: leramistat 40mg', 'Drug: Simvastatin 40mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 4: Upadacitinib 15 mg', 'interventionNames': ['Drug: leramistat 40mg', 'Drug: Upadacitinib 15 MG']}], 'interventions': [{'name': 'leramistat 40mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Part 1: Itraconazole 200mg', 'Part 2: Phenytoin 100mg', 'Part 3: Simvastatin 40mg', 'Part 4: Upadacitinib 15 mg']}, {'name': 'Itraconazole 200 mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Part 1: Itraconazole 200mg']}, {'name': 'Phenytoin 100 Mg Oral Capsule', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Part 2: Phenytoin 100mg']}, {'name': 'Simvastatin 40mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Part 3: Simvastatin 40mg']}, {'name': 'Upadacitinib 15 MG', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Part 4: Upadacitinib 15 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belfast', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Phase 1 Unit', 'role': 'CONTACT'}, {'name': 'Nadine Abdullah', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Celerion', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'centralContacts': [{'name': 'Study Team', 'role': 'CONTACT', 'email': 'ist05@istesso.co.uk', 'phone': '+44 (0)207 444 0066'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modern Biosciences Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}