Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT04981561
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2021-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of GATE-251 in Normal Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Triple blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind placebo controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2021-07-18', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent adverse events', 'timeFrame': '28 days', 'description': 'through study completion'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics, maximum plasma concentration', 'timeFrame': '24 hours', 'description': 'maximum plasma concentration'}, {'measure': 'Pharmacokinetics, time to maximum plasma concentration', 'timeFrame': '24 hours', 'description': 'time to maximum plasma concentration'}, {'measure': 'Pharmacokinetics, area under the curve for plasma concentration', 'timeFrame': '72 hours', 'description': 'area under the curve, plasma calculated 0-infinity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NMDA receptor', 'NMDA receptor positive allosteric modulator', 'pharmacokinetics', 'biomarker', 'eeg'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers', 'detailedDescription': 'Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers.\n\nSecondary objectives:\n\nTo evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of GATE-251 following increasing single doses of GATE-251.\n\nGATE-251 or Placebo: Dose/Mode of Administration: Single dose; oral'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agree to effective method of birth control\n* If female, negative pregnancy test at screening and Day -1\n* Nonsmoking at least 2 years\n* BMI 18-30\n* Supine pulse rate 30-100\n\nExclusion Criteria:\n\n* Known hypersensitivity to NMDA receptor drugs\n* clinically significant disease in any body system\n* QTcF \\> 430 ms in males, \\>450 ms in females\n* positive test for hepatitis B or C\n* abnormal liver function tests on Day -1\n* History of alcohol or other substance abuse during the previous 5 years\n* Positive drug screen at screening or Day -1\n* Taken any medication within the past 14 days'}, 'identificationModule': {'nctId': 'NCT04981561', 'briefTitle': 'Safety and Tolerability of GATE-251 in Normal Human Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syndeio Biosciences, Inc'}, 'officialTitle': 'A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': '3125-101-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 microgram GATE-251', 'description': 'GATE-251, 100 microgram tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '1 mg GATE-251', 'description': 'GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '3 mg GATE-251', 'description': 'GATE-251, 3 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '10 mg GATE-251', 'description': 'GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '25 mg GATE-251', 'description': 'GATE-251, 25 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '50 mg GATE-251', 'description': 'GATE-251, 50 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '100 mg GATE-251', 'description': 'GATE-251, 100 mg tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '1 mg GATE-251 with CSF collection', 'description': 'GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection', 'interventionNames': ['Drug: GATE-251']}, {'type': 'EXPERIMENTAL', 'label': '10 mg GATE-251 with CSF collection', 'description': 'GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection', 'interventionNames': ['Drug: GATE-251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet, PO, Single Dose with 28 day follow up', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GATE-251', 'type': 'DRUG', 'description': 'Single dose of GATE-251', 'armGroupLabels': ['1 mg GATE-251', '1 mg GATE-251 with CSF collection', '10 mg GATE-251', '10 mg GATE-251 with CSF collection', '100 mg GATE-251', '100 microgram GATE-251', '25 mg GATE-251', '3 mg GATE-251', '50 mg GATE-251']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ronald M Burch, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Syndeio Biosciences, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ronald M Burch MD PhD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'Ronald M Burch MD PhD', 'investigatorAffiliation': 'Syndeio Biosciences, Inc'}}}}