Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-28 @ 10:39 PM
Study NCT ID:
NCT04379869
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540261', 'term': 'cyclo-L-glycyl-L-2-allylproline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Stage 1: None Stage 2: Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stage 1: Open-label, single dose with 2 dose cohorts. Stage 2: Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose (MAD) with 2 dose cohorts'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability measured through Adverse Events /Serious Adverse Events', 'timeFrame': '25 days', 'description': 'The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic - Cmax', 'timeFrame': '17 days', 'description': 'Maximum observed plasma concentration (Cmax) of NNZ-2591'}, {'measure': 'Pharmacokinetic - AUC∞', 'timeFrame': '17 days', 'description': 'Area under the concentration-time curve from time 0 to infinity of NNZ-2591'}, {'measure': 'Pharmacokinetic - Tmax', 'timeFrame': '17 days', 'description': 'Time to Cmax of NNZ-2591'}, {'measure': 'Pharmacokinetic - t1/2', 'timeFrame': '17 days', 'description': 'Terminal elimination half-life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.', 'detailedDescription': 'This study is in two stages:\n\nStage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.\n\nStage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects aged 18 to 55 years, inclusive;\n2. Weight at screening and admission between 45 kg and 100 kg;\n3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;\n4. Healthy as determined by the Investigator based on pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);\n5. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening;\n6. Clinical laboratory test results up to \\>1.5 x Lower Limit of Normal (LLN) or \\<1.5 x Upper Limit of Normal (ULN) at screening and admission and deemed not clinically significant by the Investigator;\n7. Negative screen for alcohol and drugs of abuse at screening and admission;\n8. Non-smokers or ex-smokers (must have ceased smoking \\>3 months prior to screening visit);\n\n If female:\n9. Woman with no childbearing potential by reason of surgery or at least 1year post- menopause (i.e., 12 months post last menstrual period), and menopause confirmed by follicle-stimulating hormone (FSH) testing;\n10. If of childbearing potential, using an effective nonhormonal method of contraception (intrauterine device; condom or occlusive cap \\[diaphragm or cervical or vault caps\\]; true abstinence; or vasectomized male partner (provided that he is the sole partner of that subject and had a vasectomy ≥30 days prior to screening) for the duration of the study and up to one month after the last investigational medicinal product (IMP) administration;\n11. Negative serum pregnancy test at screening and negative urine pregnancy test on admission (women of childbearing potential only);\n\n If male:\n12. Using an effective method of contraception (condom) if sexually active with a female partner of child-bearing potential; true abstinence; or vasectomy ≥30 days prior to screening) throughout the study and for one month after the last IMP administration.\n\nExclusion Criteria:\n\n1. Subjects who have a clinically relevant history as determined by the Investigator, or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;\n2. Fridericia's correction factor for QT (QTcF) \\> 450 ms for male participants and \\>470ms for female participants or history of QT interval prolongation.\n3. Have a clinically relevant surgical history, as determined by the Investigator;\n4. Have a history of relevant atopy or drug hypersensitivity;\n5. Have a history of alcoholism or drug abuse;\n6. Consume more than 21 standard drinks a week for males and more than 14 standard drink if female \\[1 standard drink is any drink containing 10g of alcohol, regardless of container size or alcohol type\\].\n7. Have a significant infection or known inflammatory process on screening or admission;\n8. Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission;\n9. Have used any prescription or non-prescription medicines within 2 weeks of admission, unless in the investigator's opinion will not affect determination of safety or other study assessments. Occasional paracetamol use (up to 2g/day is permitted);\n10. Have received any investigational drug within 30 days prior to screening;\n11. Have used tobacco or nicotine products within 3 months of screening\n12. Have donated or received any blood or blood products within the 3 months prior to screening;\n13. Cannot communicate reliably with the investigator;\n14. Are unlikely to co-operate with the requirements of the study;\n15. Are unwilling or unable to give written informed consent.\n\n If female:\n16. Pregnancy or breast-feeding;\n17. Woman of childbearing potential not willing to use an accepted effective contraceptive method or using hormonal contraceptives;\n\n If male:\n18. Not willing to use an accepted effective method of contraception."}, 'identificationModule': {'nctId': 'NCT04379869', 'briefTitle': 'To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuren Pharmaceuticals Limited'}, 'officialTitle': 'A Combined Single Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'NEU-2591-HV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NNZ-2591 Single dose Cohort 1', 'description': 'Single dose of oral NNZ-2591 in healthy volunteers', 'interventionNames': ['Drug: NNZ-2591']}, {'type': 'EXPERIMENTAL', 'label': 'NNZ-2591 Single dose Cohort 2', 'description': 'Single dose of oral NNZ-2591 in healthy volunteers', 'interventionNames': ['Drug: NNZ-2591']}, {'type': 'EXPERIMENTAL', 'label': 'NNZ-2591 MAD Cohort 1', 'description': 'Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers', 'interventionNames': ['Drug: NNZ-2591', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'NNZ-2591 MAD Cohort 2', 'description': 'Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers', 'interventionNames': ['Drug: NNZ-2591', 'Drug: Placebo']}], 'interventions': [{'name': 'NNZ-2591', 'type': 'DRUG', 'description': 'Single dose of NNZ-2591', 'armGroupLabels': ['NNZ-2591 MAD Cohort 1', 'NNZ-2591 MAD Cohort 2', 'NNZ-2591 Single dose Cohort 1', 'NNZ-2591 Single dose Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Comparator for double-blind MAD', 'armGroupLabels': ['NNZ-2591 MAD Cohort 1', 'NNZ-2591 MAD Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Scientia Clinical Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Linear Clinical Research, The Queen Elizabeth II Medical Centre', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'James Shaw', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuren Pharmaceuticals'}, {'name': 'Jasmine Williams', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linear Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuren Pharmaceuticals Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}