Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-02 @ 4:09 AM
Study NCT ID:
NCT02228733
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716354', 'term': 'KBP-5074'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and tolerability', 'timeFrame': '14 days', 'description': 'Assessing the number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): pre dose and post dose'}, {'measure': 'Area Under Curve (AUC) Time Frame', 'timeFrame': '14 days', 'description': 'Assessing drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'The effect of food on Area Under Curve (AUC) Time Frame', 'timeFrame': '14 days', 'description': 'Assessing the food effect on drug exposure across time at pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose'}, {'measure': 'The plasma aldosterone, serum potassium and urine albumin levels', 'timeFrame': '14 days', 'description': 'Assessing blood levels of aldosterone, potassium and urine albumin at pre dose and postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension.', 'detailedDescription': 'This is an open-label, parallel-group, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 following a single dose administration of KBP-5074 with and without food. The study includes 2 parts.\n\nPart 1: Pharmacokinetics from each dose cohort will be characterized before initiation of dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074.\n\nPart 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed conditions. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074 under fed conditions.\n\nSerum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.\n\nThe urine samples will be also used for quantitative determination of urinary albumin in both Part 1 and Part 2.\n\nSafety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal renal function and in good general health\n\nExclusion Criteria:\n\n* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; A history of prescription drug abuse, or illicit drug use within 6 months prior to screening'}, 'identificationModule': {'nctId': 'NCT02228733', 'briefTitle': 'Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open-Label, Parallel-Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 Following Oral Administration and With a Food Effect Panel', 'orgStudyIdInfo': {'id': 'KBP5074-1-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Cohort 1', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}, {'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Cohort 2', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}, {'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Cohort 3', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}, {'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Cohort 4', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}, {'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Cohort 5', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}, {'type': 'EXPERIMENTAL', 'label': 'KBP-5074: Fed Group', 'description': 'Healthy Volunteers will receive one dose of KBP-5074', 'interventionNames': ['Drug: KBP-5074']}], 'interventions': [{'name': 'KBP-5074', 'type': 'DRUG', 'description': 'Comparisons of different doses of study drug', 'armGroupLabels': ['KBP-5074: Cohort 1', 'KBP-5074: Cohort 2', 'KBP-5074: Cohort 3', 'KBP-5074: Cohort 4', 'KBP-5074: Cohort 5', 'KBP-5074: Fed Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KBP Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}