Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT02821312
Status:
UNKNOWN
Last Update Posted:
2016-07-01
First Post:
2016-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630740', 'term': 'DA-8010'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2016-06-19', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'during 10 days in Part A', 'description': 'Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).'}, {'measure': 'Safety and Tolerability', 'timeFrame': 'during 16 days in Part B', 'description': 'Safety outcome will be assessed by incidence and severity of several items (adverse events, vital signs, electrocardiography, clinical laboratory evaluations, physical examination).'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC)', 'timeFrame': '48 hours'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '48 hours'}, {'measure': 'Time of the maximum observed plasma concentration (tmax)', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.', 'detailedDescription': 'This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.\n\nIn Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.\n\nIn Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18.0 and 32.0 kg/m2\n* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions\n\nExclusion Criteria:\n\n* Subjects who do not agree to use a method of acceptable contraception\n* Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control\n* Consume more than 28 or 21 units of alcohol per week if male or female, respective\n* Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration\n* Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration\n* Systolic blood pressure \\< 90 mmHg or \\> 140 mmHg\n* Diastolic blood pressure \\< 50 mmHg or \\> 90 mmHg\n* Pulse rate \\< 45 bpm or \\> 100 bpm\n* Positive urine drugs of abuse screen at screening or first admission\n* Positive alcohol breath test at screening or first admission\n* Positive cotinine test at screening or first admission\n* Abnormality in the 12-lead ECG at screening, admission or predose on Day 1\n* Subjects who are pregnant, breastfeeding, or lactating\n* Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration\n* Subjects who have a significant history of drug allergy, as determined by the Investigator\n* Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin \\> ULN at screening or admission\n* Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies'}, 'identificationModule': {'nctId': 'NCT02821312', 'briefTitle': 'A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DA8010_OAB_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active in Group A1~A7', 'description': 'In each of Groups A1 to A7, 8 subjects will receive DA-8010.', 'interventionNames': ['Drug: DA-8010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in Group A1~A7', 'description': 'In each of Groups A1 to A7, 2 subjects will receive placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active in Group B1~B4', 'description': 'In each of Groups B1 to B4, 8 subjects will receive DA-8010.', 'interventionNames': ['Drug: DA-8010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in Group B1~B4', 'description': 'In each of Groups B1 to B4, 2 subjects will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DA-8010', 'type': 'DRUG', 'description': 'Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010.\n\nPart B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010.', 'armGroupLabels': ['Active in Group A1~A7', 'Active in Group B1~B4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010.\n\nPart B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010.', 'armGroupLabels': ['Placebo in Group A1~A7', 'Placebo in Group B1~B4']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sujin Cho', 'role': 'CONTACT', 'email': 'csjin@donga.co.kr', 'phone': '8229208329'}], 'overallOfficials': [{'name': 'Jisu Song', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dong-A ST'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}