Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 12:49 PM
Study NCT ID:
NCT07018635
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D013844', 'term': 'Thiazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics Parameter (PK): Cmax of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as maximum observed plasma or serum concentration of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: AUC(0-t) of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the area under the concentration-time curve up to the last measurable concentration of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: AUC 0-∞ of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the area under the concentration-time curve from 0 to infinity of INCB161734.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 2 months', 'description': 'Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after first dose of study drug.'}, {'measure': 'Pharmacokinetics Parameter: Tmax of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the time to reach the maximum plasma concentration of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: t1/2 of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the apparent terminal phase disposition half-life of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: CL/V of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the apparent oral dose clearance of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: Vz/F of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as the apparent oral dose volume of distribution of INCB161734.'}, {'measure': 'Pharmacokinetics Parameter: AUC%extrap of INCB161734', 'timeFrame': 'Up to 2 months', 'description': 'Defined as percentage of AUC∞ (\\_obs, \\_pred) due to extrapolation from time of last measurable observed concentration to infinity of INCB161734.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB161734'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.incyteclinicaltrials.com/trials/INCB161734-103', 'label': 'A study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to assess the effect of itraconazole, rifampin, and acid-reducing agents on INCB161734 pharmacokinetics when administered orally in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Age 18 to 55 years, inclusive, at the time of signing the ICF.\n* Body mass index between 18.0 and 32.0 kg/m2 (inclusive).\n* Willingness to adhere to study-related prohibitions, restrictions, and procedures.\n* Ability to swallow and retain PO medication.\n* Willingness to avoid pregnancy or fathering children based on the criteria defined in the prootcol.\n\nExclusion Criteria:\n\n* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.\n* History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.\n* History of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.\n* Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.\n* Resting pulse \\< 40 bpm or \\> 100 bpm, confirmed by repeat testing at screening.\n* Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).\n* Any major surgery within 12 weeks of screening.\n* Positive test for hepatitis B virus, hepatitis C virus, or HIV. Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.\n* Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.\n* Use of tobacco- or nicotine-containing products within 1 month of screening.\n* Women who are pregnant or breastfeeding.\n* eGFR \\< 90 mL/min/1.73 m2 based on the CKD-EPI equation.\n* Any history of hypersensitivity or intolerance to itraconazole, rifampin, esomeprazole or any other PPI, or famotidine or any other H2 antagonist.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07018635', 'briefTitle': 'A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'An Open-Label Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants', 'orgStudyIdInfo': {'id': 'INCB161734-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'INCB161734 and itraconazole will be administered at protocol defined doses.', 'interventionNames': ['Drug: INCB161734', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'INCB161734 and rifampin will be administered at protocol defined doses.', 'interventionNames': ['Drug: INCB161734', 'Drug: Rifampin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'INCB161734 and esomeprazole will be administered at protocol defined doses.', 'interventionNames': ['Drug: INCB161734', 'Drug: Esomeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'INCB161734 and famotidine will be administered at protocol defined doses.', 'interventionNames': ['Drug: INCB161734', 'Drug: Famotidine']}], 'interventions': [{'name': 'INCB161734', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Cohort 1']}, {'name': 'Rifampin', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Cohort 2']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Cohort 3']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Oral; Tablet', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}