Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02745860
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Dose Strengths of Selexipag in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'interventionBrowseModule': {'meshes': [{'id': 'C523468', 'term': 'selexipag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679', 'timeFrame': 'From predose until 72 hours postdose for each treatment period', 'description': 'AUC(0-inf) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to the extrapolated infinite time'}, {'measure': 'Maximum plasma concentration (Cmax) of selexipag and ACT-333679', 'timeFrame': 'From predose until 72 hours postdose for each treatment period', 'description': 'Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679'}], 'secondaryOutcomes': [{'measure': 'Time to reach Cmax (tmax) of selexipag and ACT-333679', 'timeFrame': 'From predose until 72 hours postdose for each treatment period', 'description': 'tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679'}, {'measure': 'Terminal half-life (t½) of selexipag and ACT-333679', 'timeFrame': 'From predose until 72 hours postdose for each treatment period', 'description': 'The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half'}, {'measure': 'Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679', 'timeFrame': 'From predose until 72 hours postdose for each treatment period', 'description': 'AUC(0-t) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to time t of the last measured concentration above the limit of quantification'}, {'measure': 'Incidence of treatment-emergent adverse events and serious adverse events', 'timeFrame': 'From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)', 'description': 'A treatment-emergent AE is any AE temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests'}, {'measure': 'Incidence of safety events of interest', 'timeFrame': 'From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)', 'description': 'Events of interest include any abnormalities in ECG, vital signs or laboratory test results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['selexipag', 'pharmacokinetics'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '28639216', 'type': 'DERIVED', 'citation': 'Boehler M, Bruderer S, Ulc I, Dingemanse J. Biocomparison Study of Adult and Paediatric Dose Strengths of the Prostacyclin Receptor Agonist Selexipag. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):115-120. doi: 10.1007/s13318-017-0424-z.'}]}, 'descriptionModule': {'briefSummary': 'Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.', 'detailedDescription': 'Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag) during each of the two study periods. There is a washout of 7-9 days between the two study treatment administrations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key inclusion Criteria:\n\n* Male subjects aged from 18 to 45 years (inclusive) at screening\n* Signed informed consent form\n* Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening\n* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests\n\nKey exclusion 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* 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': 'NCT02745860', 'briefTitle': 'Comparison of Two Dose Strengths of Selexipag in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'Single-center, Open-label, Randomized, Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag (ACT-293987) Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag', 'orgStudyIdInfo': {'id': 'AC-065-112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence AB', 'description': 'Subjects receive 200 µg of selexipag (adult formulation) as a single oral dose during Period 1 and 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 2', 'interventionNames': ['Drug: Selexipag (adult formulation)', 'Drug: Selexipag (pediatric formulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BA', 'description': 'Subjects receive 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 1 and 200 µg of selexipag (adult formulation) as a single oral dose during Period 2', 'interventionNames': ['Drug: Selexipag (adult formulation)', 'Drug: Selexipag (pediatric formulation)']}], 'interventions': [{'name': 'Selexipag (adult formulation)', 'type': 'DRUG', 'otherNames': ['ACT-293987'], 'description': 'One selexipag film-coated tablet of 200 µg', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}, {'name': 'Selexipag (pediatric formulation)', 'type': 'DRUG', 'otherNames': ['ACT-293987'], 'description': 'Four selexipag film-coated tablets of 50 µg', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Margaux Boehler', 'affiliation': 'Actelion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}