Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT04207957
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2019-12-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626907', 'term': 'olorofim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum plasma concentration (Cmax) for olorofim', 'timeFrame': '35 days'}, {'measure': 'area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim', 'timeFrame': '35 days'}, {'measure': 'Absolute bioavailability of olorofim (F)', 'timeFrame': '35 days'}], 'secondaryOutcomes': [{'measure': 'Time to Cmax (TMax) for olorofim', 'timeFrame': '35 days'}, {'measure': 'area under the concentration time curve to infinity (AUC0-∞) for olorofim', 'timeFrame': '35 days'}, {'measure': 'terminal elimination half-life (t½) for olorofim', 'timeFrame': '35 days'}, {'measure': 'Number of subjects with treatment-related adverse events', 'timeFrame': '35 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as intact tablets and via NG tube'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* males or females of any ethnic origin between 18 and 55 years of age\n* subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.\n* subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations\n\nExclusion Criteria:\n\n* Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.\n* Female subjects who are pregnant or lactating.\n* Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration\n* Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration\n* Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration\n* Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator"}, 'identificationModule': {'nctId': 'NCT04207957', 'briefTitle': 'A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim', 'organization': {'class': 'INDUSTRY', 'fullName': 'F2G Biotech GmbH'}, 'officialTitle': 'A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim', 'orgStudyIdInfo': {'id': 'F901318-01-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IV', 'description': '2 h IV infusion (Groups A/B)', 'interventionNames': ['Drug: Olorofim']}, {'type': 'OTHER', 'label': 'oral (fasted)', 'description': '30 mg tablets given after an overnight fast (Groups A/B)', 'interventionNames': ['Drug: Olorofim']}, {'type': 'OTHER', 'label': 'oral (fed)', 'description': '30 mg tablets given after a high fat breakfast (Groups A/B)', 'interventionNames': ['Drug: Olorofim']}, {'type': 'OTHER', 'label': 'oral (intact tablet)', 'description': '30 mg tablets (Group C)', 'interventionNames': ['Drug: Olorofim']}, {'type': 'OTHER', 'label': 'oral (NG tube)', 'description': '30 mg tablets in water via NG tube (Group C)', 'interventionNames': ['Drug: Olorofim']}], 'interventions': [{'name': 'Olorofim', 'type': 'DRUG', 'otherNames': ['F901318'], 'description': '150 mg', 'armGroupLabels': ['IV', 'oral (NG tube)', 'oral (fasted)', 'oral (fed)', 'oral (intact tablet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Jim Bush, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance CRU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'F2G Biotech GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}