Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:32 PM
Study NCT ID:
NCT02690727
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2016-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706530', 'term': 'tenalisib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esicard@algopharm.com', 'phone': '(514) 858-6077', 'title': 'Dr. Eric Sicard', 'organization': 'Algorithme Pharma Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 7', 'description': 'Subjects who entered the study and received at lease one of the treatments under study.\n\n2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16', 'eventGroups': [{'id': 'EG000', 'title': 'RP6530 in Fast Condition', 'description': 'A single dose of RP6530 following fast condition\n\nRP6530: Single oral dose', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RP6530 in Fed Condition', 'description': 'A single dose of RP6530 following fed condition\n\nRP6530: Single oral dose', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vessel puncture site bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'vessel puncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP6530 in Fast Condition', 'description': 'A single dose of RP6530 following fast condition\n\nRP6530: Single oral dose'}, {'id': 'OG001', 'title': 'RP6530 in Fed Condition', 'description': 'A single dose of RP6530 following fed condition\n\nRP6530: Single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '5277.01', 'spread': '33.4', 'groupId': 'OG000'}, {'value': '6726.99', 'spread': '29.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '128.49', 'ciLowerLimit': '119.13', 'ciUpperLimit': '138.59', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'up to 24 hours post-dose.', 'description': 'Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.', 'unitOfMeasure': 'nanogram*hour per millilitre (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects who provided evaluable data for both treatments (Fasting and fed conditions)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Evaluated for Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP6530 in Fast Condition', 'description': 'A single dose of RP6530 following fast Condition\n\nRP6530: Single oral dose'}, {'id': 'OG001', 'title': 'RP6530 in Fed Condition', 'description': 'A single dose of RP6530 following fed Condition\n\nRP6530: Single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy volunteers'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RP6530 in Fast Condition', 'description': 'A single dose of RP6530 following fast condition\n\nRP6530: Single oral dose'}, {'id': 'OG001', 'title': 'RP6530 in Fed Condition', 'description': 'A single dose of RP6530 following fed condition\n\nRP6530: Single oral dose'}], 'classes': [{'categories': [{'measurements': [{'value': '1311.77', 'spread': '42.0', 'groupId': 'OG000'}, {'value': '1753.78', 'spread': '32.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '139.27', 'ciLowerLimit': '111.01', 'ciUpperLimit': '174.73', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'up to 24 hours post-dose.', 'description': 'Peak Plasma Concentration (Cmax)', 'unitOfMeasure': 'nanogram per millilitre (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who provided evaluable data for both treatments'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RP6530: Fast Condition First, Then Fed Condition', 'description': 'Fast Condition first, then Fed Condition\n\nRP6530: Single oral dose'}, {'id': 'FG001', 'title': 'RP6530: Fed Condition First, Then Fast Condition', 'description': 'Fed Condition first, then Fast Condition\n\nRP6530: Single oral dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'A single dose of RP6530 following fasting and Fed condition\n\nRP6530: Single oral dose'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '01', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.7', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.50', 'spread': '2.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '18 healthy volunteers were enrolled to get at least 12 completed subjects to demonstrate food effect.\n\n* Safety population included all participants who received at least 1 dose of study drug.\n* PK population included all the participants who provided PK in both period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2016-02-15', 'resultsFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-03', 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))', 'timeFrame': 'up to 24 hours post-dose.', 'description': 'Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Were Evaluated for Adverse Events', 'timeFrame': '7 days', 'description': 'Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0'}, {'measure': 'Pharmacokinetic Parameters', 'timeFrame': 'up to 24 hours post-dose.', 'description': 'Peak Plasma Concentration (Cmax)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fasting', 'Fed condition', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.', 'detailedDescription': 'The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers; aged 18 to 45 years;\n* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;\n* Non- smokers or ex-smokers;\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Subjects with evidence or history of clinically significant disease;\n* Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;\n* Subjects who have received any investigational drug in the previous 28 days;\n* Subjects participated in a study with PI3k inhibitors at least once in past year;\n* Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.'}, 'identificationModule': {'nctId': 'NCT02690727', 'briefTitle': 'To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhizen Pharmaceuticals SA'}, 'officialTitle': 'An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'RP6530-1501'}, 'secondaryIdInfos': [{'id': 'ISI-P5-416', 'type': 'OTHER', 'domain': 'Algorithme Pharma Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RP6530 in fast condition', 'description': 'A single dose of RP6530 following fast condition', 'interventionNames': ['Drug: RP6530']}, {'type': 'EXPERIMENTAL', 'label': 'RP6530 in fed condition', 'description': 'A single dose of RP6530 following fed condition', 'interventionNames': ['Drug: RP6530']}], 'interventions': [{'name': 'RP6530', 'type': 'DRUG', 'otherNames': ['A dual PI3K delta/gamma inhibitor'], 'description': 'Single oral dose', 'armGroupLabels': ['RP6530 in fast condition', 'RP6530 in fed condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3P 3P1', 'city': 'Québec', 'country': 'Canada', 'facility': 'Algorithme Pharma Inc', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Eric Sicard, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Algorithme Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhizen Pharmaceuticals SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}