Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 10:57 PM
Study NCT ID:
NCT06310304
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'INCB018424 pharmacokinetic (PK) in Plasma', 'timeFrame': 'Up to Day 22', 'description': 'INCB018424 concentration in plasma.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 55', 'description': 'Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.'}, {'measure': 'Additional INCB018424 pharmacokinetic (PK) in Plasma', 'timeFrame': 'Up to Day 22', 'description': 'Additional INCB018424 concentration in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB018424', 'Ruxolitinib', 'Healthy Participants'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Healthy adult participants aged 19 to 55 years at screening.\n* Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants in each cohort may be enrolled with a body mass index \\> 30 to ≤ 32.0 kg/m2.\n* No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).\n* Ability to swallow and retain oral medication.\n* Willingness to avoid pregnancy or fathering children based on the criteria below.\n\n * Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) and not have a partner that is currently pregnant from screening through follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n * Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test at check-in before the first dose on Day -1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n * Female participants of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 51 years of age and FSH compatible with postmenopausal status) are eligible.\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 cardiovascular, cerebrovascular, peripheral vascular or thrombotic disease or uncontrolled hypertension (blood pressure \\> 140/90 mmHg confirmed by repeat testing).\n* Resting pulse \\< 45 bpm or \\> 100 bpm, confirmed by repeat testing.\n* History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant, such as a QTcF interval \\> 450 milliseconds.\n* Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).\n* Hemoglobin, WBC count, platelet count, or absolute neutrophil count less than laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing.\n* Hepatic transaminases (ALT and AST), ALP, or total bilirubin \\> 1.25 × the laboratory-defined ULN at screening and check-in, confirmed by repeat testing (except participants with Gilbert's disease, for which total bilirubin must be ≤ 2.0 × ULN).\n* History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.\n* Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug except that appendectomy will be allowed.\n* Any major surgery within 4 weeks of screening.\n* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma only).\n* Blood transfusion within 4 weeks of check-in.\n* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).\n* Positive test for hepatitis B virus, HCV, or HIV. 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* History of alcoholism within 3 months of screening.\n* Positive urine or breath test for ethanol or positive urine screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug Protocol.\n* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of cytochrome P450 3A4, P-glycoprotein, or breast cancer resistance protein.\n* Current use of prohibited medication.\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.\n* Known hypersensitivity or severe reaction to ruxolitinib or any excipients of ruxolitinib.\n* Inability to undergo venipuncture or tolerate venous access.\n* Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.\n* Use of tobacco- or nicotine-containing products within 1 month of screening and throughout the study.\n* Use of prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations) within 7 days of study drug administration and throughout the study except for permitted medications during the study.\n* Women who are pregnant or breastfeeding.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* eGFR \\< 90 mL/min/1.73 m2 based on the site's standard formula.\n* Any condition that would jeopardize the safety of the participant or compliance with the Protocol."}, 'identificationModule': {'nctId': 'NCT06310304', 'briefTitle': 'A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants', 'orgStudyIdInfo': {'id': 'INCB18424-153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Dose Treatment A', 'description': 'Ruxolitinib IR will be administered at protocol defined dose.', 'interventionNames': ['Drug: Ruxolitinib IR']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Dose Treatment B', 'description': 'Ruxolitinib XR will be administered at protocol defined dose.', 'interventionNames': ['Drug: Ruxolitinib XR']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Dose Treatment A', 'description': 'Ruxolitinib IR will be administered at protocol defined dose.', 'interventionNames': ['Drug: Ruxolitinib IR']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Dose Treatment B', 'description': 'Ruxolitinib XR will be administered at protocol defined dose.', 'interventionNames': ['Drug: Ruxolitinib XR']}], 'interventions': [{'name': 'Ruxolitinib IR', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Tablet', 'armGroupLabels': ['Cohort 1: Dose Treatment A', 'Cohort 2: Dose Treatment A']}, {'name': 'Ruxolitinib XR', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Tablet', 'armGroupLabels': ['Cohort 1: Dose Treatment B', 'Cohort 2: Dose Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion, Inc', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}