Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02708004
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C572762', 'term': 'aprocitentan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment-emergent Adverse Events', 'timeFrame': 'From Day 1 up to End-of-Study (i.e. for at least 25 days)', 'description': 'Number of subjects with Adverse Events'}, {'measure': 'Treatment-emergent Serious Adverse Events', 'timeFrame': 'From Screening (Day -3) up to Follow-up (i.e. for at least 49 days)', 'description': 'Number of subjects with Serious Adverse Events'}, {'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': 'At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9', 'description': 'Change from baseline to each scheduled timepoint'}, {'measure': 'Fractional sodium excretion in 24 h urine samples [mmol per day]', 'timeFrame': 'At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9', 'description': 'Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint'}, {'measure': 'Fractional lithium excretion in 24 h urine samples [mmol per day]', 'timeFrame': 'At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9', 'description': 'Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint'}], 'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'from Day 1 to Day 9', 'description': 'Change from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests\n* Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening\n\nExclusion Criteria:\n\n\\- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol'}, 'identificationModule': {'nctId': 'NCT02708004', 'briefTitle': 'Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'A Single-center, Double-blind, Randomized, Placebo-controlled, Two-way Crossover Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AC-080-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACT-132577', 'description': '3 different dose levels', 'interventionNames': ['Drug: Aprocitentan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching active drug', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Aprocitentan', 'type': 'DRUG', 'otherNames': ['ACT-132577'], 'description': 'Formulated in capsules in 2 different strengths; 2 capsules per day', 'armGroupLabels': ['ACT-132577']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching active drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Investigator Site Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Idorsia Pharmaceuticals Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}