Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT01851603
Status:
TERMINATED
Last Update Posted:
2016-12-30
First Post:
2013-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, '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': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'PI left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2013-05-06', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Repeatable Battery for Assessment of Neuropsychological Status Total Scale T Score', 'timeFrame': '24 hours', 'description': 'T score on Total Scale of the Repeatable Battery for Assessment of Neuropsychological Status, differences between AVL-3288 or placebo arms and pretreatment baseline.'}, {'measure': 'P50 Auditory Sensory Gating Ratio', 'timeFrame': '24 hours', 'description': 'Ratio = (Conditioning P50 amplitude-Test P50 Amplitude)/Conditioning P50 Amplitude, differences between AVL-3288 or placebo arms from baseline.'}], 'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '48 hours', 'description': '0,1,2,3, 4, 6, 8 ,12, 24, 48 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events.', 'timeFrame': '10 days', 'description': 'Corrected QT interval \\> 500 ms; hepatic enzyme \\> 3 times above the upper limit of normal values; systolic blood pressure \\> 200 mm Hg or diastolic blood pressure \\< 50 mm Hg.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '17470817', 'type': 'BACKGROUND', 'citation': 'Ng HJ, Whittemore ER, Tran MB, Hogenkamp DJ, Broide RS, Johnstone TB, Zheng L, Stevens KE, Gee KW. Nootropic alpha7 nicotinic receptor allosteric modulator derived from GABAA receptor modulators. Proc Natl Acad Sci U S A. 2007 May 8;104(19):8059-64. doi: 10.1073/pnas.0701321104. Epub 2007 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a brief inpatient study to determine the safety of a new drug in healthy people.', 'detailedDescription': 'AVL-3288, a "first in class" small molecule, selective allosteric modulator of the α7 nAChR, is implicated in the cognitive deficit in patients with neurologic and psychiatric disorders, including schizophrenia, Alzheimer\'s disease and attention deficit hyperactivity disorder. The mechanism of action, the allosteric modulation of α7 nAChR and improvement of cognitive and memory function both in relevant animal models and patients has been clearly described in recent literature. The effect of AVL-3288 strongly supports the rationale for use in schizophrenia given the dose effect relationship, peaking at a low dose in rats (HED 3 mg), in rodent schizophrenia and memory models. Phase I, single-center, inpatient, randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety, tolerability and pharmacokinetic profiles of single oral doses of AVL-3288 in healthy subjects. Subjects will be hospitalized in the University of Colorado Clinical Research Center (CTSA) for a 12 hour period after the single dose. Then there will be an ambulatory 24 and 48 hour observation and washout period of 10. Patients will receive an evoked potential measurement, the P50 sensory gating paradigm, and the Repeatable Battery for Assessment of Neuropsychological Status.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer\n\nExclusion Criteria:\n\n* Substance use. We do not accept inquiries by email.'}, 'identificationModule': {'nctId': 'NCT01851603', 'acronym': 'AVL3288', 'briefTitle': 'Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Phase I, Single-center, Inpatient, Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Oral Doses of AVL-3288 (Anvylic-3288) Healthy Subjects.', 'orgStudyIdInfo': {'id': '12-1186'}, 'secondaryIdInfos': [{'id': '1U01MH094247', 'link': 'https://reporter.nih.gov/quickSearch/1U01MH094247', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVL-3288', 'description': 'Oral administration of AVL-3288', 'interventionNames': ['Device: AVL-3288']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AVL-3288', 'type': 'DEVICE', 'otherNames': ['UCI-4083'], 'description': 'Drug', 'armGroupLabels': ['AVL-3288']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Diluent solution'], 'description': 'Identical diluent to that used for AVL-3288', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'U of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Robert Freedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U of Colorado Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}