Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT04633733
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Fixed-sequential'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak plasma concentration at steady state(Cmax,ss) of HL237', 'timeFrame': '0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22', 'description': 'Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237'}, {'measure': 'Area under the plasma concentration versus time curve during a dosage interval(AUCτ) of HL237', 'timeFrame': '0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22', 'description': 'Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237'}, {'measure': 'Peak whole-blood concentration(Cmax) of tacrolimus', 'timeFrame': '0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22', 'description': 'Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237'}, {'measure': 'Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus', 'timeFrame': '0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22', 'description': 'Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.', 'detailedDescription': 'To evaluate the pharmacokinetic interaction by comparing of pharmacokinetic parameters when administered HL237(or tacrolimus) between with tacrolimus(or HL237) and without tacrolimus(or HL237).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male, 19 years ≤ age ≤ 45\n* Body weight ≥ 50kg and 18.5 ≤ BMI ≤ 29.9kg/m2\n* Subjects are agree to use contraceptives that protocol suggest and not provide sperm for up to 2 months after the last administration of the investigational drug\n* Volunteer\n\nExclusion Criteria:\n\n* Subject with serious cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease\n* Subject with symptoms of acute disease within 28 days prior to investigational products dosing\n* Subject with medical history which able to affect absorption, distribution, metabolism and excretion of drug\n* Subject with hypersensitive reaction to following drug or history of clinically significant hypersensitive reaction to following drug\n\n * Calcineurin inhibitor or Macrolides\n * HL237\n* Subject with clinically significant active chronic disease\n* Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption\n* Subjects who showed one or more of the following in a screening test including a retest\n\n * AST, ALT \\> UNL (upper normal limit) x 2.5\n * Creatinine clearance =\\< 80mL/min (Cockcroft-Gault GFR = (140-age) \\* (Wt in kg) / (72 \\* Cr))\n * Results of ECG, QTc \\> 450 msec\n* Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, anti-Human Immunodeficiency virus antibody or venereal disease research laboratory test\n* Use of any prescription medication within 14 days prior to study medication dosing\n* Use of any over-the-counter(OTC) medication within 7 days prior to study medication dosing\n* Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)\n* Subject who is not able to taking standard meals provided by the institution\n* Subject with whole blood donation within 60 days, component blood donation within 20 days\n* Subjects receiving blood transfusion within 30 days prior to study medication dosing\n* Participation in any clinical investigation within 6 months prior to study medication dosing\n* Use of any medication effected on drug enzyme induction or inhibition such as barbitals within 30 days prior to study medication dosing\n* Subjects who have continuously consumed grapefruit juice or caffeine (grapefruit juice or caffeine \\> 5 cups/day), or who can't refrain from intake during hospitalization\n* Subjects who have continued to drink alcohol (alcohol\\> 30 g/day) or who can't quit drinking during hospitalization\n* Severe heavy smoker(cigarette \\> 10 cigarettes per day) or subjects who can't quit smoking during hospitalization\n* Subjects that the investigator deems unsuitable for participation in the clinical trial due to laboratory test results or other excuse such as non-responding to request or instruction by investigator"}, 'identificationModule': {'nctId': 'NCT04633733', 'briefTitle': 'The Study of Pharmacokinetic Interactions Between HL237 and Tacrolimus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions Between HL237 and Tacrolimus in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'HL237-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'This single arm is conducted in fixed-sequence(Treatment A -\\>(washout period) -\\> Treatment B -\\> Treatment C -\\> Maintenance treatment).\n\nTreatment A : tacrolimus 5mg po single dose, Treatment B : HL237 400mg bid for 4 days, Treatment C: tacrolimus 5mg po single dose and HL237 400 mg bid, Maintenance treatment : HL237 400mg bid for 2 days', 'interventionNames': ['Drug: HL237 tablet', 'Drug: tacrolimus capsule']}], 'interventions': [{'name': 'HL237 tablet', 'type': 'DRUG', 'description': 'HL237 400mg will be administered orally twice a day.', 'armGroupLabels': ['Single arm']}, {'name': 'tacrolimus capsule', 'type': 'DRUG', 'description': 'tacrolimus 5mg will be administered orally once a day.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Korea Univertisy Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}