Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-03-15 @ 8:15 PM
Study NCT ID:
NCT04024332
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634383', 'term': 'daridorexant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, open-label, single-dose study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of ACT-541468', 'timeFrame': 'Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days'}, {'measure': 'Time to reach maximum plasma concentration (tmax) of ACT-541468', 'timeFrame': 'Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days'}, {'measure': 'Terminal half-life (t½) of ACT-541468', 'timeFrame': 'Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days'}, {'measure': 'Extent of plasma protein binding (PPB; in %)', 'timeFrame': 'Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days', 'description': "PPB % = 100 - (Cu/C×100), with 'Cu' standing for unbound and 'C' for total plasma ACT-541468 concentration."}], 'primaryOutcomes': [{'measure': 'AUC of ACT-541468 from time zero to 24 h after study drug administration (AUC0-inf)', 'timeFrame': 'Blood samples for PK analysis will be taken at multiple time points after ACT-541468 administration for a total duration of up to 4 days'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with treatment-emergent (serious) adverse events (S)AEs', 'timeFrame': 'During treatment with ACT-541468 administration for a total duration of up to 4 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'General inclusion criteria for all subjects:\n\n* Signed informed consent in the local language prior to any study mandated procedure.\n* Male and female subjects aged 18 to 85 years (inclusive) at screening.\n* Body mass index (BMI) from 18 to 35 kg/m2 (inclusive) at screening. Body weight at least 50 kg.\n* Women of childbearing potential: Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use (during the entire study and 30 days thereafter) a highly effective method of contraception with a failure rate of \\< 1% per year.\n* Women of non-childbearing potential, i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis: no contraceptive requirement.\n\nAdditional inclusion criteria for healthy subjects (Group A):\n\n* Normal renal function as confirmed based on Creatinine Clearance (CLcr) by the Cockcroft-Gault equation adjusted for age: \\>= 80 mL/min for subjects \\<= 50 years of age; \\>= 70 mL/min for subjects 51-60 years of age; \\>= 60 mL/min for subjects 61-85 years of age; CLcr = (\\[140-age(years)\\]×weight (kg))/(72×serum creatinine (mg/dL)) (x 0.85 for female subjects)\n* The CLcr value should be confirmed (± 25%) on Day -1 in case subjects will be dosed more than 10 days after the day of screening.\n* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.\n* Each healthy subject must be matched with one subject with severe renal function impairment with regard to age (± 10 years difference allowed), body weight (± 15% difference allowed), and sex, determined by results at screening.\n\nAdditional inclusion criteria for subjects with severe renal function impairment (Group B)\n\n* Severe renal function impairment as confirmed based on CLcr by the Cockcroft-Gault equation: \\<30 mL/min, not on dialysis.\n* The CLcr value should be confirmed (± 25%) on Day -1 since subjects will be dosed more than 10 days after the day of screening.\n* Hematology, clinical chemistry, coagulation and urinalysis test results consistent with severe renal function impairment at screening.\n* Physical examination without clinically relevant abnormalities at screening and on Day -1 (except for those related to severe renal function impairment), which would interfere with the objectives of the study.\n* Stable concomitant medications.\n\nGeneral exclusion criteria for all subjects:\n\n* Pregnant or lactating women.\n* Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal\n* History of renal and/or liver transplant.\n* Hepatic cancer, primary biliary cirrhosis or any form of cholestatic disease.\n* Use of drugs which might interfere with the PK of ACT-541468 (moderate to strong CYP3A4 inhibitors or inducers).\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\nAdditional exclusion criteria for healthy subjects (Group A)\n\n* History or clinical evidence of any unstable disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy, herniotomy, and cholecystectomy allowed).\n* Intake of any creatine supplement from screening to EOS.\n\nAdditional exclusion criteria for subjects with severe renal function impairment (Group B).\n\n\\- End-stage renal disease that requires dialysis.'}, 'identificationModule': {'nctId': 'NCT04024332', 'briefTitle': 'Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Single-dose Study to Investigate the Pharmacokinetics of ACT-541468 in Subjects With Severe Renal Impairment Compared to Healthy Subjects', 'orgStudyIdInfo': {'id': 'ID-078-115'}, 'secondaryIdInfos': [{'id': '2019-002159-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (healthy)', 'description': 'On Day 1, 8 healthy subjects will receive a single oral dose of 25 mg ACT-541468 in fasted condition.', 'interventionNames': ['Drug: ACT-541468']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (severe renal function impairment)', 'description': 'On Day 1, 8 subjects with severe renal function impairment will receive a single oral dose of 25 mg ACT-541468 in fasted condition.', 'interventionNames': ['Drug: ACT-541468']}], 'interventions': [{'name': 'ACT-541468', 'type': 'DRUG', 'description': 'ACT-541468 25 mg; administered orally', 'armGroupLabels': ['Group A (healthy)', 'Group B (severe renal function impairment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81241', 'city': 'München', 'country': 'Germany', 'facility': 'APEX GmbH', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}