Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-18 @ 7:26 PM
Study NCT ID:
NCT02390258
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630294', 'term': 'S66913'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Part 1: 13 days; Part 2: 13 days; Part 3: 22 days'}], 'secondaryOutcomes': [{'measure': 'Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration', 'timeFrame': 'Part 1: 13 days; Part 3: 22 days'}, {'measure': 'Food effect on AUC of XEN-D0103', 'timeFrame': '13 days'}, {'measure': 'Change in QTcF with XEN-D0103 and with placebo', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.\n* Females must be of non-childbearing potential\n\nExclusion Criteria:\n\n* Subject has a known heart disease.\n* Subject has any of QTcF \\> 450 msec, PR ≥ 210 msec or QRS ≥ 120 msec at screening (determined from median of three readings).\n* For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).\n* Subject has any other condition which, in the investigator's opinion will interfere with the trial.\n* Subject has a systolic blood pressure (BP) \\<80 or \\>160 mmHg at screening or a diastolic BP \\>90 or \\<45 mmHg at screening.\n* Subject has a clinically significant abnormal laboratory test result at screening.\n* Female subject who is pregnant or breast feeding and female subjects of childbearing potential."}, 'identificationModule': {'nctId': 'NCT02390258', 'briefTitle': 'Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xention Ltd'}, 'officialTitle': 'A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'XEN-D0103-CL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Single Ascending Dose - Cohort 1', 'description': '8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)', 'interventionNames': ['Drug: 10mg XEN-D0103', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Single Ascending Dose - Cohort 2', 'description': '8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)', 'interventionNames': ['Drug: Placebo', 'Drug: 30mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Single Ascending Dose - Cohort 3', 'description': '8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)', 'interventionNames': ['Drug: Placebo', 'Drug: 60mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Single Ascending Dose - Cohort 4', 'description': '8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)', 'interventionNames': ['Drug: Placebo', 'Drug: 120mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Single Ascending Dose - Cohort 5', 'description': '8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)', 'interventionNames': ['Drug: Placebo', 'Drug: 200mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Fed-Fasted', 'description': '17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast.', 'interventionNames': ['Drug: 200mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Multiple Ascending Dose - Cohort 1', 'description': '10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)', 'interventionNames': ['Drug: Placebo', 'Drug: 30mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Multiple Ascending Dose - Cohort 2', 'description': '10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)', 'interventionNames': ['Drug: Placebo', 'Drug: 60mg XEN-D0103']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: Multiple Ascending Dose - Cohort 3', 'description': '10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)', 'interventionNames': ['Drug: Placebo', 'Drug: 150mg XEN-D0103']}], 'interventions': [{'name': '10mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 1', 'Part 1: Single Ascending Dose - Cohort 2', 'Part 1: Single Ascending Dose - Cohort 3', 'Part 1: Single Ascending Dose - Cohort 4', 'Part 1: Single Ascending Dose - Cohort 5', 'Part 3: Multiple Ascending Dose - Cohort 1', 'Part 3: Multiple Ascending Dose - Cohort 2', 'Part 3: Multiple Ascending Dose - Cohort 3']}, {'name': '30mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 2', 'Part 3: Multiple Ascending Dose - Cohort 1']}, {'name': '60mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 3', 'Part 3: Multiple Ascending Dose - Cohort 2']}, {'name': '120mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 4']}, {'name': '200mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 1: Single Ascending Dose - Cohort 5', 'Part 2: Fed-Fasted']}, {'name': '150mg XEN-D0103', 'type': 'DRUG', 'armGroupLabels': ['Part 3: Multiple Ascending Dose - Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M15 6SH', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'ICON Development Solutions', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xention Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}