Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:53 PM
Study NCT ID:
NCT06324006
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2023-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Trial of LIB-01 in Healthy Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.', 'timeFrame': '14 days', 'description': 'Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE):\n\nGrade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n\nGrade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).\n\nGrade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.\n\nGrade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.'}, {'measure': 'To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.', 'timeFrame': '14 days', 'description': 'Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).'}, {'measure': 'To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.', 'timeFrame': '14 days', 'description': 'Clinically significant changes in ECG parameters (resting heart rate \\[HR\\] and PQ/PR, QRS, QT and QTcF intervals).'}, {'measure': 'To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.', 'timeFrame': '28 days', 'description': 'Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE):\n\nGrade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n\nGrade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).\n\nGrade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL.\n\nGrade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE. Clinically significant changes in vital signs, ECG and safety laboratory measurements.'}, {'measure': 'To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.', 'timeFrame': '28 days', 'description': 'Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).'}, {'measure': 'To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.', 'timeFrame': '28 days', 'description': 'Clinically significant changes in ECG parameters (resting heart rate \\[HR\\] and PQ/PR, QRS, QT and QTcF intervals).'}], 'secondaryOutcomes': [{'measure': 'To characterise the maximum plasma concentration of LIB-01, following a single oral dose.', 'timeFrame': '3 days', 'description': 'Maximum Plasma Concentration \\[Cmax\\]'}, {'measure': 'To characterise the plasma concentration half life of LIB-01, following a single oral dose.', 'timeFrame': '3 days', 'description': 'Plasma Concentration Half Life \\[T1/2\\]'}, {'measure': 'To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.', 'timeFrame': '3 days', 'description': 'Plasma Concentration Area Under Curve \\[AUC\\]'}, {'measure': 'To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.', 'timeFrame': '4 days', 'description': 'Maximum Plasma Concentration \\[Cmax\\]'}, {'measure': 'To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.', 'timeFrame': '4 days', 'description': 'Plasma Concentration Half Life \\[T1/2\\]'}, {'measure': 'To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.', 'timeFrame': '4 days', 'description': 'Plasma Concentration Area Under Curve \\[AUC\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:\n\n* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.\n* What are the pharmacokinetic characteristics of LIB-01\n\nParticipants will receive LIB-01 and be followed up for safety and pharmacokinetics by:\n\n* Adverse events\n* ECG\n* Blood sampling for laboratory parameters and pharmacokinetic analysis'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any trial specific procedures.\n2. Healthy male participant aged 18 to 65 years, inclusive.\n3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.\n4. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values.\n5. Participants must be willing to use an acceptable form of contraception and refrain from donating sperm from the administration of IMP until 3 months after the administration of IMP. Any female partner of a non-vasectomised male participant who is of child-bearing potential must use an acceptable contraceptive method from at least 2 weeks prior to the administration of IMP to 4 weeks after the administration of IMP.\n6. Understands the trial requirements.\n7. MAD participants only: Mild to moderate erectile dysfunction.\n\nExclusion criteria\n\n1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.\n2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.\n3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.\n4. Any planned major surgery within the duration of the trial.\n5. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to LIB-01.\n6. History of priapism.\n7. History of glaucoma.\n8. History of Non-Arteritic Anterior Ischemic Optic Neuropathy.\n9. History of prostatectomy or prostate surgery.\n10. Bleeding deficiencies or ongoing anticoagulant therapy that would put the participant at risk.\n11. Cardiac disease, including but not limited to uncontrolled hypertension; unstable angina; myocardial infarction or cerebrovascular accident.\n12. Any positive result for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).\n13. Abnormal vital signs.\n14. Shortened QT interval corrected according to Fridericia (QTcF), prolonged QTcF (\\>450 ms), cardiac arrhythmias or any clinically significant ECG abnormalities.\n15. Use of oral, injectable, or topical pro-erectile drugs or supplements.\n16. Use of nitrates.\n17. Ongoing antiandrogen treatment.\n18. Regular use of any prescribed or non-prescribed medications, within 2 weeks (Part I:SAD) or 4 weeks (Part II: MAD) prior to the (first) administration of IMP, except occasional intake of paracetamol, as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days.\n19. Planned treatment or treatment with another investigational drug.\n20. Current smokers or users of nicotine products.\n21. Positive screening result for drugs of abuse or alcohol.\n22. History of alcohol abuse or excessive intake of alcohol.\n23. Presence or history of drug abuse.\n24. History of, or current use of anabolic steroids."}, 'identificationModule': {'nctId': 'NCT06324006', 'briefTitle': 'A Phase 1 Trial of LIB-01 in Healthy Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dicot AB'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Parallel and Placebo-controlled Single and Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of LIB-01 in Healthy Participants.', 'orgStudyIdInfo': {'id': 'DCT3934'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIB-01', 'description': 'LIB-01 oral suspension', 'interventionNames': ['Drug: LIB-01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral suspension', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'LIB-01', 'type': 'DRUG', 'description': 'LIB-01 oral suspension', 'armGroupLabels': ['LIB-01']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo oral suspension', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75237', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Clinical Trial Consultants', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Björn Schultze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CTC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dicot AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}