Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 9:20 PM
Study NCT ID:
NCT07051993
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Area Under the Concentration-Time curve from Hour 0 to the Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'AUC Extrapolated to Infinity (AUC0-inf)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Geometric Mean Ratio and Associated 90% Confidence Interval (CI) of Cmax', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Geometric Mean Ratio and Associated 90% CI of AUC0-t', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Geometric Mean Ratio and Associated 90% CI of AUC0-inf', 'timeFrame': 'Days 1-12 (Part 1)'}], 'secondaryOutcomes': [{'measure': 'Time to Maximum Observed Concentration (tmax)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Apparent Terminal Elimination Rate Constant', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Apparent Terminal Elimination Half-Life (t1/2)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Apparent Systemic Clearance (CL/F)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)', 'timeFrame': 'Days 1-12 (Part 1)'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 16 days'}, {'measure': 'Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, days 1, 5, 9 and 12 (Part 1)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, randomized, two-part study to evaluate the relative bioavailability (rBA) of two tablet formulations compared to the capsule formulation of ZN-A-1041 (Part 1). Part 2 of the study will evaluate the effect of food and rabeprazole on the ZN-A-1041 tablet formulation. No participants were enrolled in Part 2 of the study as it has been cancelled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) within the range of 18 to 32 kg/m\\^2, inclusive\n* Negative hepatitis panel and negative HIV antibody screens\n* Negative screening test for latent Mycobacterium tuberculosis infection\n* Able to consume the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal\n* Able to fast for 8 hours prior to dosing\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder\n* Personal or family history of congenital long QT syndrome\n* History of significant hypersensitivity, intolerance, or allergy to any drug\n* History of acute GI symptoms\n* History of ophthalmological disease or clinically significant abnormality in the ophthalmic examination\n* Have significantly impaired hepatic function\n* Female who is pregnant or breastfeeding or intending to become pregnant during the study or within 90 days following the final ZN-A-1041 administration\n* Have a QTc interval corrected through use of Fredericia's formula \\>450 millisecond (msec), PR interval \\>210 msec, QRS complex \\>120 msec, or heart rate \\<50 beats per minute (bpm)\n* Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A or CYP2C8\n* Poor peripheral venous access\n* History of malignancy within 5 years prior to enrollment"}, 'identificationModule': {'nctId': 'NCT07051993', 'briefTitle': 'A Study to Evaluate the Relative Bioavailability of Two Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on ZN-A-1041 Tablet(s) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Randomized, Crossover, Two-Part Study to Evaluate the Relative Bioavailability of Two ZN-A-1041 Tablet Formulations Compared to Capsule Formulation and the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 Tablet(s) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'GP45607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: ZN-A-1041', 'description': 'Participants will be administered a single dose of ZN-A-1041 orally.', 'interventionNames': ['Drug: ZN-A-1041']}], 'interventions': [{'name': 'ZN-A-1041', 'type': 'DRUG', 'description': 'Participants will be administered either a ZN-A-1041 capsule or a tablet orally.', 'armGroupLabels': ['Part 1: ZN-A-1041']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS11 9EH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Fortrea Leeds CRU', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}