Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 6:20 AM
Study NCT ID:
NCT05812404
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634065', 'term': 'fexuprazan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2023-04-02', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}], 'secondaryOutcomes': [{'measure': 'Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan Accumulation ratio after DWP14012 multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite metabolic ratio after single dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}, {'measure': 'Fexuprazan active metabolite metabolic ratio after multiple dosing', 'timeFrame': '[Time Frame: up to 64 days]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Drug Interaction']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults aged ≥ 19 and ≤ 50 years at screening\n* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening\n\n ※ BMI (kg/m2) = body weight (kg)/\\[height (m)\\]2\n* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information\n* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.\n\nExclusion Criteria:\n\n* Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.\n* Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics\n* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \\[P-CAB\\] class, aspirin, antibiotics, etc.\n* Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.\n* Subjects with history of inherited muscle disorders\n* Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen\n* Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP\n* Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose\n* Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital\n* Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration\n* Subjects who are unable to refrain from smoking(\\>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital\n* Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(\\>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital\n* Subjects who are unable to refrain from caffein(\\>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital"}, 'identificationModule': {'nctId': 'NCT05812404', 'briefTitle': 'Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DW_DWP14012109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '* Treatment A: DWC202201 40 mg qd for 7 days\n* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days\n* Treatment C: DWP14012 40 mg qd for 14 days', 'interventionNames': ['Drug: DWP14012', 'Drug: DWC202201']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '* Treatment C: DWP14012 40 mg qd for 14 days\n* Treatment A: DWC202201 40 mg qd for 7 days\n* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days', 'interventionNames': ['Drug: DWP14012', 'Drug: DWC202201']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days\n* Treatment C: DWP14012 40 mg qd for 14 days\n* Treatment A: DWC202201 40 mg qd for 7 days', 'interventionNames': ['Drug: DWP14012', 'Drug: DWC202201']}], 'interventions': [{'name': 'DWP14012', 'type': 'DRUG', 'description': 'Potassium-competitive acid blocker', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'DWC202201', 'type': 'DRUG', 'description': 'Atorvastatin Calcium Trihydrate', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}