Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-24 @ 4:26 AM
Study NCT ID:
NCT03017495
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'C000634383', 'term': 'daridorexant'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-10', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of ACT-541468', 'timeFrame': 'PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only', 'description': 'Cmax is directly determined from the plasma concentrations-time curves of ACT-541468'}, {'measure': 'Time to reach Cmax (tmax) of ACT-541468', 'timeFrame': 'PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only', 'description': 'Tmax is directly determined from the plasma concentrations-time curves of ACT-541468'}, {'measure': 'Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468', 'timeFrame': 'PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only', 'description': 'AUC is calculated from time zero to 24 hours post dose'}, {'measure': 'Terminal half-life (t1/2) of ACT-541468', 'timeFrame': 'PK blood samples on Day 2, Day 4 and Day 8: before administration of ACT-541468 and up to 24 hours post-dose, and on Day 6 and Day 7: before ACT-541468 administration only', 'description': 't1/2 is calculated from the plasma concentrations-time curves of ACT-541468'}, {'measure': 'Maximum plasma concentration (Cmax) of midazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'Cmax is directly obtained from the plasma concentrations-time curves of midazolam'}, {'measure': 'Time to reach Cmax (tmax) of midazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'Tmax is directly obtained from the plasma concentrations-time curves of midazolam'}, {'measure': 'Area under the plasma concentration-time curve [AUC(0-24)] of midazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'AUC is calculated from time zero to 24 hours post dose'}, {'measure': 'Terminal half-life (t1/2) of midazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 't1/2 is calculated from the plasma concentrations-time curves of midazolam'}, {'measure': 'Maximum plasma concentration (Cmax) of 1-hydroxymidazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'Cmax is directly determined from the plasma concentrations-time curves of 1-hydroxymidazolam'}, {'measure': 'Time to reach Cmax (tmax) of 1-hydroxymidazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'Tmax is directly determined from the plasma concentrations-time curves of 1-hydroxymidazolam'}, {'measure': 'Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 'AUC is calculated from time zero to 24 hours post dose'}, {'measure': 'Terminal half-life (t1/2) of 1-hydroxymidazolam', 'timeFrame': 'PK blood samples on Day 1, Day 2, Day 8: before administration of midazolam and up to 24 hours post dose', 'description': 't1/2 is calculated from the plasma concentrations-time curves of 1-hydroxymidazolam'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with treatment-emergent adverse events and serious adverse events', 'timeFrame': 'From baseline to end-of-study, i.e.,maximum 5 days after Day 8'}, {'measure': 'Maximum plasma concentration (Cmax) of ACT-541468 metabolites', 'timeFrame': 'PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose'}, {'measure': 'Time to reach Cmax (tmax) of ACT-541468 metabolites', 'timeFrame': 'PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose'}, {'measure': 'Area under the plasma concentration-time curve [AUC(0-24)] of ACT-541468 metabolites', 'timeFrame': 'PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose'}, {'measure': 'Terminal half-life (t1/2) of ACT-541468 metabolites', 'timeFrame': 'PK blood samples on Day 8, before administration of ACT-541468 and up to 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food-drug interaction', 'drug-drug interaction', 'pharmacokinetics'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a CYP3A4 substrate.', 'detailedDescription': 'Food effect will be assessed by comparing the pharmacokinetic (PK) parameters of a single dose of ACT-541468 under fasted (Treatment B) and fed (Treatment C) conditions.\n\nPotential CYP3A4 inhibiting / inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone (Treatment A) and midazolam given with a single dose of ACT-541468 (Treatment B) or with multiple doses of ACT-541468 (Treatment D).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent form\n* Male subjects aged from 18 to 45 years (inclusive) at screening\n* Body mass index (BMI) from 18.0 to 30.0 kg/m2 (inclusive) at screening\n* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests\n\nExclusion Criteria:\n\n* Any contraindication to the study treatments\n* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments\n* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \\< 0\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT03017495', 'briefTitle': 'A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Open-label Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 and the Effect of Single- and Multiple-dose ACT-541468 on the Pharmacokinetics of Midazolam and Its Metabolite 1-Hydroxymidazolam in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'AC-078-104'}, 'secondaryIdInfos': [{'id': '2016-003490-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food effect and Drug-Drug interaction', 'description': 'Treatments will be given to all subjects in the same fixed sequence: Treatment A (Day 1, single dose of midazolam, fasted), Treatment B (Day 2, single dose of ACT-541468 followed by single dose of midazolam, fasted), Treatment C (Day 4, single dose ACT-541468, fed), Treatment D (multiple doses of ACT-541468 from Day 5 to Day 8 + single dose of midazolam on Day 8, fasted).', 'interventionNames': ['Drug: Midazolam', 'Drug: ACT-541468']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': '2 mg/mL oral solution', 'armGroupLabels': ['Food effect and Drug-Drug interaction']}, {'name': 'ACT-541468', 'type': 'DRUG', 'description': 'Hard gelatin capsules for oral use at a strength of 25 mg', 'armGroupLabels': ['Food effect and Drug-Drug interaction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Investigator Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Marie-Laure Boof, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Actelion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}