Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06391593
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD, PK, and Safety of ALTO-203 in Patients With MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D059445', 'term': 'Anhedonia'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study will consist of two treatment periods. The initial Single-Dose Treatment Period is a randomized, double-blind, placebo-controlled 3-way crossover design with oral administration of a single dose of ALTO-203 25 μg, ALTO-203 75 μg, and matching placebo. In the subsequent Multi-Dose Parallel-Group Treatment Period, participants will receive ALTO-203 25 μg, ALTO-203 75 μg, or matching placebo randomized 1:1:1 for a total of 28 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS).', 'timeFrame': 'Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3', 'description': "The Bond-Lader Visual Analogue Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 VAS measurements of different mood state. For each question, the participants will rate their feelings at the time of assessment by indicating the point on the 10 cm line which best represents their mood. Each item is scored by measuring the position relative to the left-hand end of the line. The combined domains of alertness and mood will be assessed for the primary endpoint."}, {'measure': 'Multi-Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the multi-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.', 'timeFrame': 'Multi-Dose Treatment Period Day 1 to Day 35', 'description': 'Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.'}], 'secondaryOutcomes': [{'measure': 'Single Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the single-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo.', 'timeFrame': 'Single-Dose Treatment Period Day 1 to Day 21', 'description': 'Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.'}, {'measure': 'Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation', 'timeFrame': 'Multi-Dose Treatment Period Day 1 to Day 35', 'description': 'Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Anhedonia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days.\n\nParticipants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of moderate major depressive disorder (MDD)\n* Presence of anhedonia symptoms\n* Not taking antidepressant at Screening Visit 2\n* Willing to comply with all study assessments and procedures\n\nExclusion Criteria:\n\n* Evidence of unstable medical condition\n* Diagnosed bipolar disorder, psychotic disorder, or dementia\n* Concurrent use of prohibited medications\n* Current moderate or severe substance use disorder\n* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device'}, 'identificationModule': {'nctId': 'NCT06391593', 'briefTitle': 'PD, PK, and Safety of ALTO-203 in Patients With MDD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alto Neuroscience'}, 'officialTitle': 'Double-Blind, Single and Multiple Dose Study to Determine Pharmacodynamic Markers, Pharmacokinetic Parameters, and Safety of ALTO-203 in Patients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'ALTO-203-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALTO-203 25 μg', 'description': 'Drug: ALTO-203 25 μg\n\nSingle-Dose Treatment Period: Single Dose, ALTO-203 25 μg\n\nMulti-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days', 'interventionNames': ['Drug: ALTO-203 25 μg']}, {'type': 'EXPERIMENTAL', 'label': 'ALTO-203 75 μg', 'description': 'Drug: ALTO-203 75 μg\n\nSingle-Dose Treatment Period: Single Dose, ALTO-203 75 μg\n\nMulti-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days', 'interventionNames': ['Drug: ALTO-203 75 μg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo\n\nSingle-Dose Treatment Period: Single Dose, Placebo\n\nMulti-Dose Treatment Period: Placebo, administered orally, once daily for 28 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALTO-203 25 μg', 'type': 'DRUG', 'description': 'Active, ALTO-203 25 μg', 'armGroupLabels': ['ALTO-203 25 μg']}, {'name': 'ALTO-203 75 μg', 'type': 'DRUG', 'description': 'Active, ALTO-203 75 μg', 'armGroupLabels': ['ALTO-203 75 μg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Comparator, Placebo-to-match', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 4058', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Site 4082', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '90504', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Site 4023', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '34711', 'city': 'Clermont', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 4059', 'geoPoint': {'lat': 28.54944, 'lon': -81.77285}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 4005', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30030', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site 4031', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 4054', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Site 4036', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Site 4022', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Site 4134', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 4075', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '78737', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 4040', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 4072', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84015', 'city': 'Clinton', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 4007', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 4033', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alto Neuroscience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}