Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 1:18 PM
Study NCT ID:
NCT03935568
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Company ceased operations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Adverse Event (AE) incidence and changes from baseline in clinical laboratory test results. Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment.'}, {'measure': 'To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Adverse event incidence and changes from baseline in Electrocardiogram. Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment.'}, {'measure': 'To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Adverse event incidence and changes from baseline in vital signs . Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment.'}], 'secondaryOutcomes': [{'measure': 'To determine the pharmacokinetics (PK) PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Maximum observed concentration (Cmax).'}, {'measure': 'To determine the pharmacokinetics (PK) PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Time to maximum observed concentration (tmax).'}, {'measure': 'To determine the pharmacokinetics (PK) PU-AD in healthy subjects', 'timeFrame': 'Day 1 to Day 3', 'description': 'Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Area under the concentration-time curve (AUC).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PU-AD'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '36281667', 'type': 'DERIVED', 'citation': 'Silverman MH, Duggan S, Bardelli G, Sadler B, Key C, Medlock M, Reynolds L, Wallner B. Safety, Tolerability and Pharmacokinetics of Icapamespib, a Selective Epichaperome Inhibitor, in Healthy Adults. J Prev Alzheimers Dis. 2022;9(4):635-645. doi: 10.14283/jpad.2022.71.'}]}, 'descriptionModule': {'briefSummary': 'This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.', 'detailedDescription': 'This is a Phase 1, double-blind trial in two parts. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo and a multiple ascending dose study in 2 cohorts. Each subject in all cohorts will be administered an oral solution of PU AD or placebo under fasting conditions. Each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female (Women of non-child bearing potential)\n2. 18 to 60 years of age for part one, \\>/= 60 years of age for part two\n\nExclusion Criteria:\n\n1. Women of child bearing potential or Female with positive pregnancy test or who is lactating.\n2. History or presence of conditions, which in the judgment of the PI, are known to interfere with the absorption distribution, metabolism, or excretion of drugs.\n3. History or presence of conditions that may place the subject at increased risk as determined by the PI.\n4. Has taken other investigational drugs or participated in any clinical study within 30 days.\n5. Any other condition or prior therapy that, in the PI's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures"}, 'identificationModule': {'nctId': 'NCT03935568', 'briefTitle': 'A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Samus Therapeutics, Inc.'}, 'officialTitle': 'A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PU-AD-01-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Dose Placebo', 'description': 'Patients randomized to receive Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single Dose Active (PU-AD)', 'description': 'Patients randomized to receive Active (PU-AD)', 'interventionNames': ['Drug: PU-AD']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose (Placebo)', 'description': 'Patients randomized to receive Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose Active (PU-AD)', 'description': 'Patients randomized to receive Active (PU-AD)', 'interventionNames': ['Drug: PU-AD']}], 'interventions': [{'name': 'PU-AD', 'type': 'DRUG', 'description': '3 cohorts receiving a single oral dose of PU-AD at one time.', 'armGroupLabels': ['Single Dose Active (PU-AD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 cohorts receiving a single oral dose of Placebo at one time', 'armGroupLabels': ['Single Dose Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 cohorts receiving multiple oral dose of Placebo at one time', 'armGroupLabels': ['Multiple Dose (Placebo)']}, {'name': 'PU-AD', 'type': 'DRUG', 'description': '2 cohorts receiving multiple oral dose of PU-AD at one time', 'armGroupLabels': ['Multiple Dose Active (PU-AD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Michael H Silverman, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samus Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}