Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05260658
Status:
COMPLETED
Last Update Posted:
2023-09-05
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of CFTX-1554 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Day -1 through Day 13 (Single Ascending Dose study part) or Day 26 (Multiple Ascending Dose study part)', 'description': 'Number of Participants With Adverse Events Following Oral Administration of CFTX-1554 in SAD (Part A) and MAD (Part B)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study will consist of 2 parts, i.e. a single ascending dose part with integrated food effect assessment and assessment of relative bioavailability (Part A), and a multiple ascending dose part (Part B).\n\nPart A will have a randomized, double-blind, placebo-controlled design. Subjects will receive single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition) in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under fasted conditions (Period 1) (1 single dose level only) will be assessed.\n\nPart B will have a randomized, double-blind, placebo-controlled design, assessing multiple ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Body mass index 18.0 to 30.0 kg/m2\n* Females may be of childbearing potential but not pregnant or lactating, or of nonchildbearing potential; all females will be required to have a negative serum pregnancy test conducted at screening, (each) admission, and follow-up.\n* Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to first administration of study drug until 90 days after the follow up visit.\n* Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit.\n* All prescribed medication must have been stopped at least 30 days prior to first admission to the clinical research center.\n* All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to first admission to the clinical research center.\n* Ability and willingness to abstain from alcohol from 48 hours before screening and first admission to the clinical research center.\n* Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours before first admission to the clinical research center.\n* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.\n* Willing and able to sign the Informed Consent Form.\n\nEXCLUSION CRITERIA:\n\n* Previous participation in the current study\n* History of relevant drug and/or food allergies\n* Allergy or hypersensitivity to active ingredient or excipients of the study drug\n* Using nicotine-containing products within 60 days prior to the first study drug administration\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year before screening\n* Positive drug and alcohol screen in urine (opiates, methadone, cocaine, amphetamines \\[including ecstasy\\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, nicotine metabolites \\[cotinine\\], and alcohol) at screening or at one of the admissions to the clinical research center\n* Average intake of \\>24 units of alcohol/week\n* Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies\n* Participation in a drug study within 30 days prior to the first study drug administration in the current study (counting from the follow-up visit to the screening visit). Participation in ≥4 other drug studies in the 12 months before the first study drug administration in the current study\n* Donation or loss of \\>450 mL of blood within 60 days pribefore the first study drug administration. Donation or loss of \\>1.5 L of blood in male subjects) or \\>1.0 L of blood in female subjects in the 10 months before the first study drug administration in the current study.\n* Significant and/or acute illness within 5 days before the first study drug administration that may impact safety assessments, in the opinion of the Investigator.\n* Unwillingness to consume the Food and Drug Administration (FDA) breakfast or intolerance to any of the ingredients of the FDA breakfast (Cohort A5 only)\n* Vaccination against SARS-CoV-2 planned between 2 weeks before first admission and follow-up.\n* Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1, or any known contact with a person who tested positive for SARS-CoV-2 or with a COVID 19 patient within 2 weeks before admission.'}, 'identificationModule': {'nctId': 'NCT05260658', 'briefTitle': 'Safety and Tolerability of CFTX-1554 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Confo Therapeutics'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CFTX-1554 in Healthy Subjects, With Comparison of Intake of CFTX-1554 as Liquid Formulation and as Capsule, and After a High-fat Breakfast Versus Fasted', 'orgStudyIdInfo': {'id': 'CFTX1554-C101'}, 'secondaryIdInfos': [{'id': '2021-006368-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: CFTX-1554 Single Ascending Dose (SAD)', 'description': 'Up to 7 dose levels with CFTX-1554 administered as oral liquid formulation under fasted conditions (at 1 single dose level only, drug intake under fed conditions, and as capsule under fasted conditions and under fed conditions, will be assessed)', 'interventionNames': ['Drug: CFTX-1554']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A placebo', 'description': 'Single placebo administration in study Part A', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: CFTX-1554 Multiple Ascending Dose (MAD)', 'description': 'Up to 4 dose levels with CFTX-1554 in Part B. Doses and dosing frequency will be decided based on the results of study Part A.', 'interventionNames': ['Drug: CFTX-1554']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B placebo', 'description': 'Multiple placebo administration in study Part B', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CFTX-1554', 'type': 'DRUG', 'description': 'CFTX-1554 is a new chemical entity that binds to the angiotensin II type 2 receptor (AT2R).', 'armGroupLabels': ['Part A: CFTX-1554 Single Ascending Dose (SAD)', 'Part B: CFTX-1554 Multiple Ascending Dose (MAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'CFTX-1554 matching placebo', 'armGroupLabels': ['Part A placebo', 'Part B placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Paolo Vicini, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Confo Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Confo Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}