Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02062203
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624313', 'term': 'vadadustat'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-10', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following AKB-6548 administration.', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Placebo-corrected change-from-baseline heart rate (HR), PR interval, QRS interval', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}, {'measure': 'Categorical outliers defined as QTcF >450 msec, 480 msec and 500 msec at any timepoint and change-from-baseline QTcF (ΔQTcF) >30 msec (increased by 30 msec) and >60 msec', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}, {'measure': 'Categorical outliers for HR, PR interval, QRS interval', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}, {'measure': 'Frequency of T wave morphology changes', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}, {'measure': 'Placebo-corrected change-from-baseline QTcF (ΔΔQTcF) following moxifloxacin administration', 'timeFrame': 'multiple timepoint evaluations from pre-dose to 24 hours post-dose'}, {'measure': 'Safety parameters to include adverse events; changes in routine clinical laboratory measures including chemistry, hematology, and urinalysis; and clinically significant changes noted during physical examinations or in vital signs', 'timeFrame': 'from first dose of study medication through the final protocol required visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Akebia', 'QT interval', 'TQT', 'pharmacokinetic', 'anemia', 'chronic kidney disease', 'CKD', 'chronic renal insufficiency', 'renal impairment', 'safety'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of single oral therapeutic and supratherapeutic doses of AKB-6548 on the QT interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Healthy, non-smoking males or females, 18 and 55 years of age, inclusive\n* BMI 18.0 and 32.0 kg/m2, inclusive\n* non clinically significant 12-lead ECG\n* heart rate of 45 to 90 beats per minute, inclusive\n* mean systolic blood pressure \\<141 mmHg and mean diastolic blood pressure \\< 90 mmHg\n\nKey Exclusion Criteria:\n\n* history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease\n* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias, or torsades de pointes, structural heart disease, or a family history of Long QT syndrome\n* significant abnormalities in liver function tests\n* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs\n* history of Gilbert's Syndrome\n* positive hepatitis panel\n* seizure disorder or receiving anti-epilepsy medication for seizure disorder\n* any acute or chronic condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this study or which would limit the subject's ability to complete and/or participate in this clinical study"}, 'identificationModule': {'nctId': 'NCT02062203', 'briefTitle': 'Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'A Phase 1, Single-Center, Partially Double-Blinded, Active and Placebo Controlled, Randomized 4-Way Crossover Study to Evaluate the Effect of AKB-6548 on Cardiac Repolarization Intervals in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKB-6548 (therapeutic dose)', 'interventionNames': ['Drug: AKB-6548 (therapeutic dose)']}, {'type': 'EXPERIMENTAL', 'label': 'AKB-6548 (supratherapeutic dose)', 'interventionNames': ['Drug: AKB-6548 (supratherapeutic dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'AKB-6548 (therapeutic dose)', 'type': 'DRUG', 'description': 'Single oral dose of AKB-6548 at a therapeutic dose level', 'armGroupLabels': ['AKB-6548 (therapeutic dose)']}, {'name': 'AKB-6548 (supratherapeutic dose)', 'type': 'DRUG', 'description': 'Single oral dose of AKB-6548 at a supratherapeutic dose level', 'armGroupLabels': ['AKB-6548 (supratherapeutic dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single oral dose of placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'Single oral dose of 400 mg moxifloxacin', 'armGroupLabels': ['Moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'Akebia Therapeutics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}