Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 8:18 AM
Study NCT ID:
NCT04807335
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2021-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CT001 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of CT001 in the blood', 'timeFrame': 'baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose', 'description': 'maximum concentration over time C(max),'}, {'measure': 'Total amount of CT001 in the blood over time', 'timeFrame': 'baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose', 'description': 'Area under the curve calculated from t=0 to t= 48 hours'}], 'secondaryOutcomes': [{'measure': 'distribution and elimination of CT001', 'timeFrame': 'baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose', 'description': 'Volume of distribution'}, {'measure': 'number of study participants with adverse events', 'timeFrame': 'from baseline to 48 hours post dose', 'description': 'Number andproportion of adverse events,'}, {'measure': 'elimination of CT001', 'timeFrame': 'from baseline to 48 hours', 'description': 'Half time'}, {'measure': 'vital signs', 'timeFrame': 'from baseline to 48 hours', 'description': 'heart rate, blood pressure, respiratory rate and blood oxygen level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bioavailability']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cessatech.com', 'label': "sponsor's homepage"}]}, 'descriptionModule': {'briefSummary': 'A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.', 'detailedDescription': 'A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 up to 55 years\n* Non-smokers\n* Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)\n* Physical Status Class 1 or 2\n* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.\n\nExclusion Criteria:\n\n* Mental illness\n* Opioid Risk Tool score of \\>3\n* Pain Catastrophizing Scale score, total points \\>30\n* Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression\n* Daily intake of analgesics\n* History of alcohol or drug abuse or use of illicit drugs.\n* Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication.\n* Participant showing abnormal nasal cavity/airway\n* History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.\n* Positive tests for HIV, hepatitis B and hepatitis C\n* Positive COVID-19 test or clinical symptoms of COVID-19\n* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial\n* Blood donation within 4 weeks prior to the first dosing visit'}, 'identificationModule': {'nctId': 'NCT04807335', 'briefTitle': 'Study of CT001 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cessatech A/S'}, 'officialTitle': 'Bioavailability Study of Intranasal CT001 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'PDC 01-0204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational medicinal product CT001', 'description': 'intranasal dosage of CT001', 'interventionNames': ['Drug: CT001']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator 1', 'description': 'Ketamine 10mg iv', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator 2', 'description': 'Sufentanil 10mcg iv', 'interventionNames': ['Drug: sufentanil']}], 'interventions': [{'name': 'CT001', 'type': 'DRUG', 'description': 'nasal spray', 'armGroupLabels': ['Investigational medicinal product CT001']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'iv single dose', 'armGroupLabels': ['Comparator 1']}, {'name': 'sufentanil', 'type': 'DRUG', 'description': 'iv single dose', 'armGroupLabels': ['Comparator 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'DK', 'country': 'Denmark', 'facility': 'Dantrials', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Mads Werner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cessatech A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dantrials Aps', 'class': 'INDUSTRY'}, {'name': 'Smerud Medical Research International AS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}