Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05019105
Status:
TERMINATED
Last Update Posted:
2022-09-02
First Post:
2021-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 ALKS 1140 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'Up to 28 days'}, {'measure': 'Change in Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to 28 days', 'description': 'Change in C-SSRS measured in Multiple-Ascending Dose subjects only'}, {'measure': '12-lead safety ECG results', 'timeFrame': 'Up to 28 days', 'description': 'ECG parameters (Heart Rate, RR, PR, QRS, QT, QTcF, T wave) will be analysed using descriptive summary statistics (mean, standard deviation, median, minimum, and maximum for continuous variables) and as a change from baseline by dose level and treatment group. For the QT interval assessment, clinically abnormal ECG results for QTcF will be tabulated by protocol-specified millisecond range categories by dose and treatment group. Potentially clinically significant findings will be summarized by dose and treatment group.'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) for ALKS 1140', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29'}, {'measure': 'Half-life (t1/2) of ALKS 1140', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours'}, {'measure': 'Time until first quantifiable concentration (tlag)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29'}, {'measure': 'Apparent volume of distribution at terminal phase (Vz/F)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 hours and Day 29'}, {'measure': 'Apparent total clearance following oral administration (CL/F)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29'}, {'measure': 'Change from baseline in QTcF (Fridericia method) interval in response to treatment (Holter monitoring)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29'}, {'measure': 'Accumulation Index (RA)', 'timeFrame': 'Measured at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and Day 29'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Nervous System Diseases']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of ALKS 1140 in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥18 and \\<30 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant illness or disease including significant cardiac, gastrointestinal (stomach)\n* Subjects who have known allergic reactions to food or medications\n* Women of childbearing potential\n* Any clinically significant lifetime history of suicidal behavior or ideation (thoughts)\n* Subject had lymphoma, leukemia, or any malignancy within the past 5 years'}, 'identificationModule': {'nctId': 'NCT05019105', 'briefTitle': 'Phase 1 ALKS 1140 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Escalating Doses of ALKS 1140 With a Pilot Evaluation of Food Effect in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'ALKS 1140-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered orally', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ALKS 1140', 'description': 'Up to 8 single ascending doses of ALKS 1140 and 4 multiple ascending doses administered orally', 'interventionNames': ['Drug: ALKS 1140']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral matching placebo', 'armGroupLabels': ['Placebo']}, {'name': 'ALKS 1140', 'type': 'DRUG', 'description': 'Active oral dose of ALKS 1140', 'armGroupLabels': ['ALKS 1140']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'Alkermes Clinical Investigative Site', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}