Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-05 @ 12:22 AM
Study NCT ID:
NCT05491733
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2022-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of APX001 High-load and Low-load Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'C536972', 'term': 'Torulopsis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570438', 'term': 'APX001A'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06433128', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Area Under the Curve From Time Zero to 24 hours (AUC0-24)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Percentage of Area Under the Curve Extrapolated to Infinity (%AUCextra)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Apparent Terminal Elimination Rate Constant (λz)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Apparent Total clearance, Calculated as Dose/AUCinf (CL/F)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Apparent Volume of Distribution at Terminal Phase (Vz/F)', 'timeFrame': 'Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose'}, {'measure': 'Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)', 'timeFrame': 'Baseline through Day 14'}, {'measure': 'Number of Participants With Change From Baseline in Laboratory Tests Results', 'timeFrame': 'Baseline through Day 14'}, {'measure': 'Number of Participants With Clinically Significant Change in Vital Signs', 'timeFrame': 'Baseline through Day 14'}, {'measure': 'Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline through Day 14'}, {'measure': 'Number of Participants With Abnormalities in Physical Examinations', 'timeFrame': 'Baseline through Day 14'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fosmanogepix', 'candida', 'aspergillus', 'scedosporium', 'fusarium', 'mucorales', 'rhizopus'], 'conditions': ['Invasive Fungal Infections']}, 'descriptionModule': {'briefSummary': 'A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.\n* Minimum body weight of 50 kg.\n* Screening hematology, clinical chemistry, coagulation, and urinalysis consistent with overall good health and having an estimated glomerular filtration rate (eGFR) \\>80 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula.\n\nExclusion Criteria:\n\n* Having any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.\n* History or presence of neurological disorders including abnormal movements or seizures.\n* History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.\n* Significant and/or acute illness or chronic infection, as judged by the investigator, including, but not limited to: upper airway infection, urinary tract infection, or skin infection within 30 days prior to the first study drug administration.\n* Taking any drug or herbal CYP3A modulator (e.g., erythromycin; St. John's Wort) within 4 weeks (or 5 half-lives, whichever is longer) or any other nutrients known to modulate CYP3A activity (e.g., grapefruit juice; Seville orange) within 2 weeks prior to the first admission."}, 'identificationModule': {'nctId': 'NCT05491733', 'briefTitle': 'A Bioequivalence Study of APX001 High-load and Low-load Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'A 3-Treatment, 3-Period, 6-Sequence Randomized Crossover Single-Dose Study Evaluating the Bioequivalence of High-Load and Low-Load Oral Tablet Formulations of Apx001 and the Effect of Food on the Absorption of Apx001 From the High-Load Tablet In Healthy Subjects', 'orgStudyIdInfo': {'id': 'APX001-108'}, 'secondaryIdInfos': [{'id': 'C4791008', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'APX001 Treatment A', 'description': 'Oral tablet with a 25% drug load (low-load) in fasted participants', 'interventionNames': ['Drug: APX001', 'Drug: APX001A']}, {'type': 'EXPERIMENTAL', 'label': 'APX001A Treatment B', 'description': 'Oral tablet with a high drug load in fasted participants', 'interventionNames': ['Drug: APX001', 'Drug: APX001A']}, {'type': 'EXPERIMENTAL', 'label': 'APX001A Treatment C', 'description': 'Oral tablet with a high drug load in participants that are not fasted.', 'interventionNames': ['Drug: APX001', 'Drug: APX001A']}], 'interventions': [{'name': 'APX001', 'type': 'DRUG', 'otherNames': ['fosmanogepix'], 'description': 'Low-load oral tablet', 'armGroupLabels': ['APX001 Treatment A', 'APX001A Treatment B', 'APX001A Treatment C']}, {'name': 'APX001A', 'type': 'DRUG', 'otherNames': ['fosmanogepix'], 'description': 'High-load oral tablet', 'armGroupLabels': ['APX001 Treatment A', 'APX001A Treatment B', 'APX001A Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pharmaceuticals Research Associates, Inc', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Marc Engelhardt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Basilea Pharmaceutica International Ltd, Allschwil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basilea Pharmaceutica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}