Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 3:06 PM
Study NCT ID:
NCT01413932
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2011-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-03-09', 'releaseDate': '2018-02-07'}, {'resetDate': '2018-06-15', 'releaseDate': '2018-05-16'}], 'estimatedResultsFirstSubmitDate': '2018-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'dispFirstSubmitDate': '2015-11-17', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2011-08-04', 'dispFirstSubmitQcDate': '2015-11-17', 'studyFirstSubmitQcDate': '2011-08-09', 'dispFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day plasma PK profile of HT-2157', 'timeFrame': '7-day', 'description': 'To assess the multiple dose (7-day) plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F) of HT-2157 (and its metabolite) administered in the fed state to healthy male and female subjects'}, {'measure': 'To assess the brain penetration of HT-2157', 'timeFrame': '21-days', 'description': 'To assess the brain penetration (PK \\[including Cmax, Tmax, AUC if possible\\] in cerebrospinal fluid \\[CSF\\]) of HT-2157 (and its metabolite)'}, {'measure': 'PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 patients with MDD', 'timeFrame': '21-days', 'description': 'To assess the PD profile (CSF and peripheral biomarkers, exploratory biologic and pharmacodynamic markers of potential efficacy) of multiple (21-day) doses of HT-2157 administered in the fed state to patients with MDD'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of multiple (7-day) doses of HT-2157', 'timeFrame': '7-days', 'description': 'To assess the safety and tolerability of multiple (7-day) doses of HT-2157 administered in the fed state to healthy male and female subjects. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.'}, {'measure': 'Safety and tolerability of multiple (21-day) ascending-doses of HT 2157', 'timeFrame': '21-days', 'description': 'To assess the safety and tolerability of multiple (21-day) ascending-doses of HT 2157 administered in the fed state to patients with MDD. Change from baseline will be assessed for the following measures: Vital signs, 12-lead ECG, laboratory (hematology, chemistry, urinalysis), physical examinations, and adverse events.'}, {'measure': '21-day ascending-dose plasma PK profile of HT-2157', 'timeFrame': '21-days', 'description': 'To assess the multiple (21-day) ascending-dose plasma PK profile (including AUC, Cmax, Tmax, T1/2, CL/F, Lambda z, VZ/F, RaCmax, RaAUC) of HT-2157 (and its metabolite) administered in the fed state to patients with MDD'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers (Part 1)', 'Major Depressive Disorder (Part 2)']}, 'descriptionModule': {'briefSummary': 'This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 in healthy normal volunteers\n\nPart 2 is a randomized, double-blind, placebo-controlled, multiple (21-day) ascending-dose evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-2157 in patients with major depressive disorder', 'detailedDescription': 'This is a two part study. The objective of Part 1 is to evaluate the safety, tolerability, and pharmacokinetics of HT-2157 administered for 7-days in healthy normal volunteers\n\nPart 2 is a randomized, double-blind, placebo-controlled, multiple ascending-dose evaluation of the safety, tolerability, pharmacokinetics of HT-2157 administered for 21-days in patients with major depressive disorder. The primary objective of Part 2 is to assess the CNS penetration of HT-2157 in cerebrospinal fluid. In addition, the potential activity of HT-2157 in this patient population may be assessed using exploratory biologic and pharmacodynamic markers of potential efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main Inclusion Criteria (Part 1)\n\n* No clinically relevant abnormalities\n* Age 18 to 55 years, inclusive\n* Body Mass Index (BMI) of 18.5 to 32 kg/m2\n\nMain Inclusion Criteria (Part 2)\n\n* No clinically relevant abnormalities\n* Age 18 to 55 years, inclusive\n* Body Mass Index (BMI) of 18.5 to 32 kg/m2\n* Mild-to-Moderate major depressive disorder\n\nMain Exclusion Criteria (Part 1)\n\n\\- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs\n\nMain Exclusion Criteria (Part 2)\n\n* Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs\n* Current and primary Axis I disorder other than MDD'}, 'identificationModule': {'nctId': 'NCT01413932', 'briefTitle': 'Pharmacokinetics - Pharmacodynamic Study of HT-2157 in Healthy Subjects and in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dart NeuroScience, LLC'}, 'officialTitle': 'A Two-part Study: Part 1 is a Multiple-dose (7-day), Open-label Evaluation of the Safety, Tolerability, and Pharmacokinetics of HT-2157 in Healthy Subjects. Part 2 is a Randomized, Double-blind, Placebo-controlled, Multiple (21-day) Ascending-dose Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-2157 in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'HT-2157-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HT-2157', 'interventionNames': ['Drug: HT-2157']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HT-2157', 'type': 'DRUG', 'description': 'QD oral dosing', 'armGroupLabels': ['HT-2157']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'QD oral dosing', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Philip Perera, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dart NeuroScience, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dart NeuroScience, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-02-07', 'type': 'RELEASE'}, {'date': '2018-03-09', 'type': 'RESET'}, {'date': '2018-05-16', 'type': 'RELEASE'}, {'date': '2018-06-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dart NeuroScience, LLC'}}}}