Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT05673603
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment
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': 'C000619932', 'term': 'brensocatib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose on Days 1 to 14', 'description': 'Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Brensocatib', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose on Days 1 to 14'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose on Days 1 to 14'}, {'measure': 'Number of Participants who Experienced at Least one Adverse Event (AE)', 'timeFrame': 'Up to Day 14', 'description': 'Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brensocatib', 'INS1007'], 'conditions': ['Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '39574348', 'type': 'DERIVED', 'citation': 'Yeung SA, Stein DS, Marbury TC, Usansky H. The pharmacokinetics of brensocatib in participants with renal impairment following a single oral administration. Br J Clin Pharmacol. 2025 Apr;91(4):1191-1197. doi: 10.1111/bcp.16344. Epub 2024 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a body mass index (BMI) 18 to 35 kilograms per square meter (kg/m\\^2), inclusive, and a body weight of ≥50 kg at Screening.\n\nInclusion Criteria (for Participants With Renal Impairment):\n\n* Mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (eGFR) and calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n* Renal insufficiency or other related concomitant medical conditions (e.g., hypertension, anemia) has remained stable for at least 3 months before study drug dosing.\n\nInclusion Criteria for Healthy Participants:\n\n* Normal renal function as determined by eGFR and calculated using the CKD-EDI formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.\n* In good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings.\n\nExclusion Criteria:\n\n* Positive test result for human immunodeficiency virus types 1 or 2 antibodies, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies.\n* History of relevant drug and/or food allergies (i.e., allergy to brensocatib or any excipients, or any significant food allergy).\n* The participant has received study drug in another investigational study within 30 days of Screening.\n\nExclusion Criteria (for Participants With Renal Impairment):\n\n* Has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin \\<3.0 grams per deciliter (g/dL), and then confirmed if proteinuria \\>5 g/day.\n* Has an extrarenal cause of renal impairment (e.g., rapidly growing, space occupying lesions, adrenal enlargement).\n* Has a functioning renal transplant (participant may be included in the study if he or she had a failed renal transplant and is not taking immunosuppressants).\n* Has a hemoglobin value less than 8.5 g/dL.\n* Has Type 1 or Type 2 diabetes mellitus.\n\nExclusion Criteria (for Healthy Participants):\n\n* Has used any prescription (excluding hormonal birth control, hormone replacement therapy, nonsteroidal anti-inflammatory drugs, or acetaminophen) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before study drug dosing and throughout the study.\n\nNote: Other inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05673603', 'briefTitle': 'A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Insmed Incorporated'}, 'officialTitle': 'A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment', 'orgStudyIdInfo': {'id': 'INS1007-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Mild Impairment): Brensocatib', 'description': 'Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Moderate Impairment): Brensocatib', 'description': 'Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (Severe Impairment): Brensocatib', 'description': 'Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.', 'interventionNames': ['Drug: Brensocatib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 (Normal): Brensocatib', 'description': 'Healthy participants with normal renal function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with renal impairment.', 'interventionNames': ['Drug: Brensocatib']}], 'interventions': [{'name': 'Brensocatib', 'type': 'DRUG', 'otherNames': ['INS1007'], 'description': 'Oral tablet', 'armGroupLabels': ['Cohort 1 (Mild Impairment): Brensocatib', 'Cohort 2 (Moderate Impairment): Brensocatib', 'Cohort 3 (Severe Impairment): Brensocatib', 'Cohort 4 (Normal): Brensocatib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'USA002', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USA003', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'USA001', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insmed Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}