Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-11 @ 7:16 PM
Study NCT ID:
NCT03892902
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634383', 'term': 'daridorexant'}, {'id': 'C515050', 'term': 'zopiclone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4-way cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2', 'timeFrame': 'On Day 2 at 9 hours post dose. Duration of the test: 1 hour', 'description': 'SDLP = standard deviation of the lateral position'}, {'measure': 'Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 5', 'timeFrame': 'On Day 5 at 9 hours post dose. Duration of the test: 1 hour', 'description': 'SDLP = standard deviation of the lateral position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nGeneral criteria:\n\n* Signed informed consent prior to any study-mandated procedure.\n* Male and female subjects aged between 50 and 80 years (inclusive) at Screening.\n* Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.\n* Women of non-childbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).\n\nStudy-specific criteria\n\n* Subject has a valid driving license for more than 5 years, has driven at least 3000 km/year on average in the past 2 years.\n* Normal visual acuity (corrected or uncorrected).\n\nExclusion Criteria:\n\nGeneral criteria:\n\n* Pregnant or lactating women.\n* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.\n* History or presence of rhythm disorders\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nStudy-specific criteria:\n\n* Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.\n* History of alcoholism, drug abuse, or regular use of sedative drugs or hypnotics within 3 years prior to Screening.\n* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). One unit is equivalent to a half-pint (approx. 250 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.\n* Modified Swiss Narcolepsy Scale total score \\< 0 at Screening or history of narcolepsy or cataplexy.\n* Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.'}, 'identificationModule': {'nctId': 'NCT03892902', 'briefTitle': 'A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 4-way Cross-over Study to Assess Next-day Driving Performance Following Single and Multiple Evening Administrations of ACT-541468 in Middle-aged and Elderly Subjects', 'orgStudyIdInfo': {'id': 'ID-078-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A (50 mg ACT-541468)', 'description': '1 tablet of ACT-541468 50 mg + 1 tablet of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period A.', 'interventionNames': ['Drug: ACT-541468', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B (100 mg ACT-541468)', 'description': '2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.', 'interventionNames': ['Drug: ACT-541468', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C (7.5 mg zopiclone)', 'description': '2 tablets of ACT-541468 matching placebo + 1 capsule of zopiclone 7.5 mg administered in the evening on Days 1 and 4 of Treatment Period C. In the evenings of Days 2 and 3, subjects will receive placebo (i.e., 2 tablets of ACT-541468 matching placebo + zopiclone matching placebo).', 'interventionNames': ['Drug: Zopiclone 7.5 mg', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D (placebo)', 'description': '2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ACT-541468', 'type': 'DRUG', 'description': 'Film-coated tablet for oral use at a dose strength of 50 mg.', 'armGroupLabels': ['Treatment A (50 mg ACT-541468)', 'Treatment B (100 mg ACT-541468)']}, {'name': 'Zopiclone 7.5 mg', 'type': 'DRUG', 'description': 'Over-encapsulated to maintain blinding.', 'armGroupLabels': ['Treatment C (7.5 mg zopiclone)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching to maintain blinding.', 'armGroupLabels': ['Treatment A (50 mg ACT-541468)', 'Treatment B (100 mg ACT-541468)', 'Treatment C (7.5 mg zopiclone)', 'Treatment D (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Clinical Pharmacologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Idorsia Pharmaceuticals Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}