Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT02881294
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705512', 'term': 'samelisant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-21', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under concentration (AUC)', 'timeFrame': '96 hours'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cognitive Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect\n* Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect\n\nExclusion Criteria:\n\n* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.\n* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.\n* Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody\n* History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT02881294', 'briefTitle': 'A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suven Life Sciences Limited'}, 'officialTitle': 'A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CTP1S23031H3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Food Effect', 'description': 'SUVN-G3031 tablets single dose', 'interventionNames': ['Drug: SUVN-G3031']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gender Effect', 'description': 'SUVN-G3031 tablets single dose', 'interventionNames': ['Drug: SUVN-G3031']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Age Effect', 'description': 'SUVN-G3031 tablets single dose', 'interventionNames': ['Drug: SUVN-G3031']}], 'interventions': [{'name': 'SUVN-G3031', 'type': 'DRUG', 'armGroupLabels': ['Age Effect', 'Food Effect', 'Gender Effect']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Quintiles', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suven Life Sciences Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}