Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-03-11 @ 6:42 AM
Study NCT ID:
NCT03155503
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2017-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'subjects randomized to drug or placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-25', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-13', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG (Electrocardiogram)', 'timeFrame': 'Range of Day 1-17', 'description': 'electrocardiogram outcomes'}, {'measure': 'Vital signs', 'timeFrame': 'Range of Day 1-17', 'description': 'blood pressure determination'}, {'measure': 'C-SSRS (Columbia Suicidal Severity Rating Scale)', 'timeFrame': 'Range of Day 1-17', 'description': 'Columbia Suicidal Severity Rating in multiple doses'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Plasma concentration'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Maximum concentration observed'}, {'measure': 'Time to reach maximum concentration (Tmax)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Determination of maximum time taken to reach the maximum concentration'}, {'measure': 'Terminal half-life (t½)', 'timeFrame': 'Day 1 and Day 14', 'description': 'Elimination rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SUVN-911', 'Depression', 'single dose', 'multiple dose', 'alpha4 beta2 receptor', 'first in human', 'safety', 'pharmacokinetics', 'tolerability'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '35963959', 'type': 'DERIVED', 'citation': 'Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.', 'detailedDescription': 'This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.\n\nThe primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible.\n\nThe secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male aged 18 to 45 years with a body mass index (BMI) between 18 and 30 kg/m2, (inclusive).\n\nExclusion Criteria:\n\n* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects:\n\n * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.\n * History or presence of gastro intestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator."}, 'identificationModule': {'nctId': 'NCT03155503', 'acronym': 'SUVN-911', 'briefTitle': 'A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suven Life Sciences Limited'}, 'officialTitle': 'A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CTP1S1911A4B2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single ascending dose', 'description': 'Single dose of SUVN-911 or placebo in healthy male subjects', 'interventionNames': ['Drug: SUVN-911', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multiple ascending dose', 'description': 'Multiple doses of SUVN-911 or placebo in healthy male subjects', 'interventionNames': ['Drug: SUVN-911', 'Drug: Placebo']}], 'interventions': [{'name': 'SUVN-911', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Multiple ascending dose', 'Single ascending dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Multiple ascending dose', 'Single ascending dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'QuintilesIMS Phase 1 Services, LLC', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Barbara Lomeli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suven Life Sciences Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}