Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 2:44 AM
Study NCT ID:
NCT03467100
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2018-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs) as assessed by CTCAE v4.03', 'timeFrame': 'From screening (28 days prior to Day 1) through to 30 days post-final dose', 'description': 'To assess AEs as a criteria of safety and tolerability'}, {'measure': 'Resting 12-lead electrocardiogram (ECG)', 'timeFrame': 'At screening (28 days prior to Day 1) through to 7 days post-final dose', 'description': 'To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'At screening (28 days prior to Day 1) through to 7 days post-final dose', 'description': 'To assess vital signs as a criteria of safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 1 predose through to 7 days post-final dose', 'description': 'Cmax is the maximum observed plasma concentration in ng/mL'}, {'measure': 'Time to the Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Day 1 predose through to 7 days post-final dose', 'description': 'Tmax is the time in hours to reach Cmax following dosing'}, {'measure': 'Terminal elimination half-life (t1/2)', 'timeFrame': 'Day 1 predose through to 7 days post-final dose', 'description': 'The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase'}, {'measure': 'Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)', 'timeFrame': 'Day 1 predose through to 7 days post-final dose', 'description': 'The area under the plasma concentration-time curve \\[in ng.h/mL\\] from time zero to the time corresponding to the last quantifiable plasma concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2\n* Must agree to use effective methods of contraception, if applicable\n* Able to swallow capsules\n* Able to provide written, personally signed and dated Informed Consent Form\n\nKey Exclusion Criteria:\n\n* Any history of seizures\n* Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject\'s ability to participate in the study\n* Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale\n* Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study\n* No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end\n* No smoking 60 days prior to dosing to study end\n* Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations'}, 'identificationModule': {'nctId': 'NCT03467100', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xenon Pharmaceuticals Inc.'}, 'officialTitle': 'Phase 1, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'XPF-006-101'}, 'secondaryIdInfos': [{'id': '2017-004046-26', 'type': 'EUDRACT_NUMBER'}, {'id': 'QCL118145', 'type': 'OTHER', 'domain': 'Quotient Sciences Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XEN901', 'description': 'Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort', 'interventionNames': ['Drug: XEN901']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort', 'interventionNames': ['Drug: Inert Ingredients Oral Product']}], 'interventions': [{'name': 'XEN901', 'type': 'DRUG', 'description': 'Capsule filled with XEN901', 'armGroupLabels': ['XEN901']}, {'name': 'Inert Ingredients Oral Product', 'type': 'DRUG', 'description': 'Placebo capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Gregory Beatch, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xenon Pharmaceuticals Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xenon Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}