Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06717269
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of PK parameters: NX-5948 tablets versus capsules', 'timeFrame': '9 weeks', 'description': 'Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (AUC)'}, {'measure': 'Assessment of PK parameters: NX-5948 tablets versus capsules', 'timeFrame': '9 weeks', 'description': 'Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Cmax)'}, {'measure': 'Assessment of PK parameters NX-5948 tablets versus capsules', 'timeFrame': '9 weeks', 'description': 'Relative bioavailability of NX-5948 tablet, compared to capsule, will be measured using PK parameters (Tmax)'}, {'measure': 'Food effect and effect of esomeprazole on AUC0-t for single-dose NX-5948 tablet', 'timeFrame': '9 weeks', 'description': 'Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet'}, {'measure': 'Food effect and effect of esomeprazole on AUC0-inf for single-dose NX-5948 tablet', 'timeFrame': '9 weeks', 'description': 'Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet'}, {'measure': 'Food effect and effect of esomeprazole on Cmax for single-dose NX-5948 tablet', 'timeFrame': '9 weeks', 'description': 'Evaluate the effect of food and the effect of multiple doses of esomeprazole on the single-dose PK of NX-5948 tablet'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy, adult, male or female 19-55 years of age\n* Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead safety ECGs at the screening visit, as deemed by the PI or designee\n* Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.\n\nKey Exclusion Criteria:\n\n* Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study\n* Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders\n* History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948\n* History or presence of alcohol or drug abuse within the past 2 years\n* History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds\n* History or presence of:\n\n * Significant multiple and/or severe allergies, including anaphylactic reaction.\n * Personal or family history of prolonged QT syndrome or family history of sudden cardiac death.\n * Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff Parkinson-White Syndrome, or cardiac pacemaker.\n * Adrenal insufficiency.\n * Skin infection.\n* Female volunteers of childbearing potential\n* Female volunteer with a positive pregnancy test\n* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit\n* Donation of blood or significant blood loss within 56 days prior to the first dosing\n* Plasma donation within 7 days prior to the first dosing\n* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n* Previous exposure to NX-5948.\n* Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.'}, 'identificationModule': {'nctId': 'NCT06717269', 'briefTitle': 'Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nurix Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label Study in Healthy Volunteers to Evaluate the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, and the Effect of Food and an Acid-reducing Agent on the Pharmacokinetics of NX-5948', 'orgStudyIdInfo': {'id': 'NX-5948-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NX-5948 tablet and capsule under fasted and fed conditions', 'interventionNames': ['Drug: NX-5948']}, {'type': 'EXPERIMENTAL', 'label': 'NX-5948 tablet and capsule combined with esomeprazole under fasted conditions', 'interventionNames': ['Drug: NX-5948', 'Drug: Esomeprazole']}], 'interventions': [{'name': 'NX-5948', 'type': 'DRUG', 'description': 'Administered orally in tablet or capsule form', 'armGroupLabels': ['NX-5948 tablet and capsule combined with esomeprazole under fasted conditions', 'NX-5948 tablet and capsule under fasted and fed conditions']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Administered orally in capsule form', 'armGroupLabels': ['NX-5948 tablet and capsule combined with esomeprazole under fasted conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'centralContacts': [{'name': 'Angie Badgett, MBA', 'role': 'CONTACT', 'email': 'angie.badgett@celerion.com', 'phone': '402-437-6351'}, {'name': 'Allen Hunt, MD', 'role': 'CONTACT', 'email': 'allen.hunt@celerion.com', 'phone': '402-437-6351'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nurix Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nurix Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}