Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-01 @ 3:55 AM
Study NCT ID:
NCT07012005
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723101', 'term': 'BPN14770'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-02', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of BPN14770', 'timeFrame': '0 (predose) up to 240 hours postdose on Day 1 to Day 11'}, {'measure': 'Time to Reach Cmax (Tmax) of BPN14770', 'timeFrame': '0 (predose) up to 240 hours postdose on Day 1 to Day 11'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of BPN14770', 'timeFrame': '0 (predose) up to 240 hours postdose on Day 1 to Day 11'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to Day 15'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll Participants:\n\n* Considered to be healthy (for healthy participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical/surgical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram (ECG) during the screening period and upon admission to the clinical research unit (CRU).\n* Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to \\<40.0 kg/square meter (m\\^2) (inclusive)\n\nParticipants With Renal Impairment:\n\n* Participants that are not undergoing hemodialysis and have severe renal impairment based upon their 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine formula creatinine clearance estimate (CLcr) estimated glomerular filtration rate (eGFR) estimate and the participant's body surface area (BSA) calculated at the screening visit\n\n a. Severe renal impairment: eGFR \\<30 milliliters (mL)/minute (min)\n* A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit.\n\nHealthy Participants:\n\n* Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 mL/min)\n* Matched to each participant with severe renal impairment with respect to sex, age (± 10 years), and BMI (± 10%)\n\nExclusion Criteria:\n\nAll Participants:\n\n* History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the judgement of the investigator\n* Current or chronic history of liver disease or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)\n* History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function\n* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Participants with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the participant's renal function will be determined by the investigator.\n* Any condition requiring medication and/or other treatment other than protocol-specified medication for participants with renal impairment, such as dietary restriction and physical therapy\n* Participant with poor venous access\n* History of Coronavirus Disease 2019 (COVID-19) infection within 14 days prior to the screening visit or admission to the CRU, or close contact with a COVID-19 patient in the 14 days prior to the screening visit or admission to the CRU as reported by the participant and the participant's medical history.\n* Sensitivity to the study intervention, or components thereof, or a drug or other allergy, including food allergy, that in the opinion of the investigator or medical monitor contraindicates participation in the study.\n\nParticipants With Renal Impairment:\n\n* Participant with acute renal failure or a kidney transplant history or requiring renal dialysis during the study period\n* Current or anticipated need for hemodialysis during the study\n\nNOTE: Other protocol-specified inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT07012005', 'briefTitle': 'Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Severe Renal Impairment and Healthy Control Participants', 'orgStudyIdInfo': {'id': '2415A4113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.', 'interventionNames': ['Drug: BPN14770']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Participants With Normal Renal Function', 'description': 'Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.', 'interventionNames': ['Drug: BPN14770']}], 'interventions': [{'name': 'BPN14770', 'type': 'DRUG', 'description': 'BPN14770 will be administered per schedule specified in the arm description.', 'armGroupLabels': ['Group 1: Participants With Severe Renal Impairment', 'Group 2: Participants With Normal Renal Function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Division of Clinical Pharmacology, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'role': 'CONTACT', 'email': 'Shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}