Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT02538367
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-30', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)', 'timeFrame': 'Day 1 pre-dose (0 hr) ~ 24 hrs post-dose'}, {'measure': 'AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)', 'timeFrame': 'Day 1 pre-dose (0 hr) ~ 24 hrs post-dose'}, {'measure': 'Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)', 'timeFrame': 'Day 1 pre-dose (0 hr) ~ 24 hrs post-dose'}, {'measure': 'C(IR multiple dose cohort)', 'timeFrame': 'Day 5, 10, 12 and 13', 'description': 'CD5, CD10, CD12, CD13'}, {'measure': 'Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)', 'timeFrame': 'Day 14'}, {'measure': 'Cmax,ss (DR single dose cohort)', 'timeFrame': 'Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose'}, {'measure': 'AUClast (DR single dose cohort)', 'timeFrame': 'Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose'}, {'measure': 'C(DR multiple dose cohort and Multiple low-dose IR cohort)', 'timeFrame': 'Day 5, 13 and 14', 'description': 'CD5, CD13, CD14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Functional Constipation']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be willing and able to provide written informed consent.\n2. BMI within the range 18 to 25 kg/m2.\n\nExclusion Criteria:\n\n1. History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.\n2. Clinically significant lab/ECG abnormalities in the opinion of the investigator.\n3. WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.\n\n Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.\n4. WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.\n5. WOCBP who are pregnant or breastfeeding.\n6. WOCBP with a positive pregnancy test prior to randomization.\n7. Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.\n8. Presence of uncontrolled or severe medical illness.\n9. Presence of a disease that require surgery at any time during the study.'}, 'identificationModule': {'nctId': 'NCT02538367', 'briefTitle': 'Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation', 'orgStudyIdInfo': {'id': 'YH12852-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 0.05mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 0.05mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 0.1mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 0.1mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 0.3mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 0.3mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 0.5mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 0.5mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 1mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 1mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 2mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 2mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 IR 3mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 IR 3mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 DR1 0.5mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 DR1 0.5mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 DR1 1mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 DR1 1mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 DR1 2mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 DR1 2mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 DR1 4mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 DR1 4mg']}, {'type': 'EXPERIMENTAL', 'label': 'YH12852 DR2 8mg', 'description': 'Once daily', 'interventionNames': ['Drug: YH12852 DR2 8mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prucalopride 2mg', 'description': 'Once daily', 'interventionNames': ['Drug: Prucalopride 2mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'YH12852 IR 0.05mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 0.05mg']}, {'name': 'YH12852 IR 0.1mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 0.1mg']}, {'name': 'YH12852 IR 0.3mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 0.3mg']}, {'name': 'YH12852 IR 0.5mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 0.5mg']}, {'name': 'YH12852 IR 1mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 1mg']}, {'name': 'YH12852 IR 2mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 2mg']}, {'name': 'YH12852 IR 3mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 IR 3mg']}, {'name': 'YH12852 DR1 0.5mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 DR1 0.5mg']}, {'name': 'YH12852 DR1 1mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 DR1 1mg']}, {'name': 'YH12852 DR1 2mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 DR1 2mg']}, {'name': 'YH12852 DR1 4mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 DR1 4mg']}, {'name': 'YH12852 DR2 8mg', 'type': 'DRUG', 'armGroupLabels': ['YH12852 DR2 8mg']}, {'name': 'Prucalopride 2mg', 'type': 'DRUG', 'armGroupLabels': ['Prucalopride 2mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Howard Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital and College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}