Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT04966832
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this double-blind study, participants will be randomized to XW10508 or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity, and causality of adverse events (AEs)', 'timeFrame': 'Up to 12 Days'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax)', 'timeFrame': '48 hours'}, {'measure': 'Trough concentration (Cmin)', 'timeFrame': '48 hours'}, {'measure': 'Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration', 'timeFrame': '48 hours'}, {'measure': 'AUC from time 0 extrapolated to infinity (AUC0-inf)', 'timeFrame': '48 hours'}, {'measure': 'AUC over the dosing interval (AUCtau)', 'timeFrame': '48 hours'}, {'measure': 'Apparent terminal half-life (t1/2)', 'timeFrame': '48 hours'}, {'measure': 'Cmax and AUC ratios of metabolites to XW10172', 'timeFrame': '48 hours'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.', 'detailedDescription': 'This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female participants who are 18 to 55 years of age, inclusive.\n* Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant (in the opinion of the investigator) gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), metabolic, psychiatric, neurological, immunological, or endocrine disorders, or allergic disease including drug allergies, including immediate type hypersensitivity to components of the study drug. A history of childhood asthma that has resolved is acceptable.\n* Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or positive urine cotinine test at Screening or Day -1.\n* Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.'}, 'identificationModule': {'nctId': 'NCT04966832', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'XWPharma'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults', 'orgStudyIdInfo': {'id': 'XW10508-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XW10508', 'description': 'XW10508 capsules or tablets', 'interventionNames': ['Drug: XW10508']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules or tablets', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'XW10508', 'type': 'DRUG', 'description': 'XW10508 capsules or tablets', 'armGroupLabels': ['XW10508']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsules or tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Daniel M Canafax, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'XWPharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XWPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}