Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 10:15 PM
Study NCT ID:
NCT04206657
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2019-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-05', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma KHK7580 concentration at each time point', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Plasma Half-Life (t1/2) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}, {'measure': 'Apparent systemic clearance (CL/F) of KHK7580', 'timeFrame': 'pre-dose, 0.25, 0.5,1,2,3,4,6,8,12,24,36,48,72 hours post-dose for single dose cohort; pre-dose, 0.25, 0.5,1,2,3,4,8,12,16 hours post dose of Day -1 and pre-dose, 2,4,8,12,16,24,36,48,72,96 hours post-dose of Day 8 for multiple dose cohort'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events (TEAEs)', 'timeFrame': 'Dosing to study completion'}, {'measure': 'QTcF', 'timeFrame': '[Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12'}, {'measure': 'QTcB', 'timeFrame': '[Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12'}, {'measure': 'intact PTH level', 'timeFrame': '[Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12'}, {'measure': 'serum P level', 'timeFrame': '[Single dose] baseline to Day 4; [Multiple dose] baseline to Day 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the pharmacokinetic profile of KHK7580 in Chinese healthy adult volunteers. The secondary objective is to evaluate its safety and pharmacodynamics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Personally submitted written voluntary informed consent to participate in the study;\n2. Chinese adult ≥20 and \\<40 years of age at informed consent;\n3. BMI ≥18.5 kg/m2 and \\<25.0 kg/m2 at screening.\n\nExclusion Criteria:\n\nSubjects must be excluded from the study if they meet any of the following criteria:\n\n1. Subjects with present illness requiring treatment;\n2. Subjects in whom the serum Ca concentration, as measured at pretreatment (screening and Day -1) blood chemistry examination, is below the lower limit of the in-house reference value;\n3. Subjects in whom a clinically significant abnormality in the crystalline lens is noted at a pre-study ophthalmological examination;\n4. Subjects with urinary tract lithiasis or its past history;\n5. Subjects with convulsive seizure or its past history;\n6. Subjects with digestive system disorder (peptic ulcer, reflux esophagitis, etc.) or its past history (in this regard, however, a past history of appendicitis is acceptable);\n7. Subjects with mental disorder or its past history;\n8. Subjects who have alcohol/drug dependence or tested positive for any of the drug abuse test items;\n9. Subjects with symptomatic allergy disease;\n10. Subjects with drug allergy or its past history;\n11. Subjects with a past history or family history of congestive heart failure, hypokalemia, or long QT syndrome; Protocol Number: 7580-202 (ver. 1.2) Date: 25 April, 2019 CONFIDENTIAL 7\n12. Subjects in whom a 12-lead ECG tracing before initiation of study drug administration showed, in the judgment of the investigator or subinvestigator, a clinically significant abnormality or an electrocardiographic waveform shape unfit for QT interval measurement;\n13. Subjects who tested positive for any of the infection test items;\n14. Subjects who have used any drugs (including over-the-counter drugs, external preparations, vitamin preparations, and herbal preparations) within 2 weeks before initiation of study drug administration;\n15. Subjects who have smoked a cigarette or used a treatment aid to smoking cessation (including nicotine-containing product chewing/ingestion and nicotine-containing patches) within 2 weeks before initiation of the study drug administration;\n16. Subjects who have participated in a clinical study of a drug and practically received the drug within 4 months before initiation of the study drug administration;\n17. Subjects who, within 3 months before initiation of the study drug administration, have been hospitalized, undergone surgery, or undergone collection of at least 200 mL of blood (including blood donation and blood component donation);\n18. Subjects who did not consent to use an effective contraceptive (e.g., use of condoms) alone or in combination between the day of hospitalization and 3 months after the end of the study drug administration;\n19. Pregnant, lactating, possibly pregnant subjects/women (subjects/women of childbearing potential with positive pregnancy test at screening or Day -1, or with negative pregnancy test at screening and Day -1 not using any contraceptive methods), or unwilling to use adequate contraception according to the physician's instructions. Amenorrhea for ≥12 months after the last menstrual period without an alternative medical cause is considered as non-childbearing potential;\n20. Prior exposure to KHK7580;\n21. Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator."}, 'identificationModule': {'nctId': 'NCT04206657', 'briefTitle': 'Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Pharmacokinetic Study of KHK7580 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '7580-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose administration of 1mg KHK7580', 'interventionNames': ['Drug: 1mg KHK7580']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose administration of 3mg KHK7580', 'interventionNames': ['Drug: 3mg KHK7580']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose administration of 6mg KHK7580', 'interventionNames': ['Drug: 6mg KHK7580']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose administration of 12mg KHK7580', 'interventionNames': ['Drug: 12mg KHK7580']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple dose administration of 6mg KHK7580 for 8days', 'interventionNames': ['Drug: 6mg KHK7580 for 8days']}], 'interventions': [{'name': '1mg KHK7580', 'type': 'DRUG', 'description': 'Single oral dose administration of 1mg KHK7580', 'armGroupLabels': ['Single dose administration of 1mg KHK7580']}, {'name': '3mg KHK7580', 'type': 'DRUG', 'description': 'Single oral dose administration of 3mg KHK7580', 'armGroupLabels': ['Single dose administration of 3mg KHK7580']}, {'name': '6mg KHK7580', 'type': 'DRUG', 'description': 'Single oral dose administration of 6mg KHK7580', 'armGroupLabels': ['Single dose administration of 6mg KHK7580']}, {'name': '12mg KHK7580', 'type': 'DRUG', 'description': 'Single oral dose administration of 12mg KHK7580', 'armGroupLabels': ['Single dose administration of 12mg KHK7580']}, {'name': '6mg KHK7580 for 8days', 'type': 'DRUG', 'description': 'multiple oral dose administration of 6mg KHK7580 for 8days', 'armGroupLabels': ['Multiple dose administration of 6mg KHK7580 for 8days']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyowa Kirin China Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}