Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT06194032
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2023-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'This study is double-blinded with regard to treatment (baxdrostat or placebo), for all placebo-controlled dose groups (groups where placebo and active substance is given in a cohort, ie, the sponsor, the investigator, all clinical staff involved in the clinical study (except for the unblinded pharmacist), the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding). Moxifloxacin will be administered as an open-label positive control in this study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placebo corrected change from baseline in QTcF (ΔΔQTcF)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of single doses of baxdrostat on QTcF compared to placebo using a concentration-QTcF analysis will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate (HR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on HR will be assessed.'}, {'measure': 'RR interval', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on RR interval will be assessed.'}, {'measure': 'PR interval', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on PR interval will be assessed.'}, {'measure': 'QRS interval', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on QRS interval will be assessed.'}, {'measure': 'Change from baseline in Heart rate (ΔHR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on HR will be assessed.'}, {'measure': 'QT interval', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on QT interval will be assessed.'}, {'measure': 'Change from baseline in RR interval (ΔRR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔRR interval will be assessed.'}, {'measure': 'Change from baseline in PR interval (ΔPR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔPR interval will be assessed.'}, {'measure': 'Change from baseline in QRS interval (ΔQRS)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔQRS interval will be assessed.'}, {'measure': 'Change from baseline in QTcF (ΔQTcF)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔQTcF will be assessed.'}, {'measure': 'Change from baseline in QT interval (ΔQT)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔQT interval will be assessed.'}, {'measure': 'Number of participants with significant change in QTcF', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for QTcF after baxdrostat administration will be assessed.'}, {'measure': 'Number of participants with significant change in PR interval', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for PR interval after baxdrostat administration will be assessed.'}, {'measure': 'Number of participants with significant change in QRS interval', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for QRS interval after baxdrostat administration will be assessed.'}, {'measure': 'Number of participants with significant change in RR interval', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for RR interval after baxdrostat administration will be assessed.'}, {'measure': 'Number of participants with significant change in QT interval', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for QT interval after baxdrostat administration will be assessed.'}, {'measure': 'Number of participants with significant change in HR', 'timeFrame': 'Day 1 to Day 3', 'description': 'The presence of categorical outliers for HR after baxdrostat administration will be assessed.'}, {'measure': 'Placebo corrected change from baseline in HR (ΔΔHR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔΔHR will be assessed.'}, {'measure': 'Placebo corrected change from baseline in RR interval (ΔΔRR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔΔRR interval will be assessed.'}, {'measure': 'Placebo corrected change from baseline in PR interval (ΔΔPR)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔΔPR interval will be assessed.'}, {'measure': 'Placebo corrected change from baseline in QRS (ΔΔQRS)', 'timeFrame': 'Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose', 'description': 'The effect of baxdrostat on ΔΔQRS interval will be assessed.'}, {'measure': 'AUClast of Baxdrostat', 'timeFrame': 'Day 1 to Day 3', 'description': 'The PK of baxdrostat will be assessed.'}, {'measure': 'AUCinf of Baxdrostat', 'timeFrame': 'Day 1 to Day 3', 'description': 'The PK of baxdrostat will be assessed.'}, {'measure': 'Maximum observed plasma peak concentration (Cmax) of baxdrostat', 'timeFrame': 'Day 1 to Day 3', 'description': 'The PK of baxdrostat will be assessed.'}, {'measure': 'Time to reach peak or maximum observed concentration (Tmax) of baxdrostat', 'timeFrame': 'Day 1 to Day 3', 'description': 'The PK of baxdrostat will be assessed.'}, {'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)', 'description': 'The safety and tolerability of baxdrostat will be assessed.'}, {'measure': 'Number of participants with Adverse events of special interest', 'timeFrame': 'Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)', 'description': 'The safety and tolerability of baxdrostat will be assessed. For this clinical study, AESIs include the following: hyperkalaemia, hyponatraemia, and hypotension events that require intervention.'}, {'measure': 'Number of treatment-emergent changes in T-wave morphology', 'timeFrame': 'Day 1 to Day 3', 'description': 'Morphological changes in the T-wave after baxdrostat administration will be assessed.'}, {'measure': 'Number of treatment-emergent changes in U-waves presence and morphology', 'timeFrame': 'Day 1 to Day 3', 'description': 'Morphological changes in the U wave after baxdrostat administration will be assessed.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aldosterone synthase inhibitor', 'QT/QTc interval', 'Moxifloxacin'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6970C00004&attachmentIdentifier=da978a59-c890-4e0a-b691-ca078d43a795&fileName=D6970C00004_Redacted_CSR_Synopsis.pdf&versionIdentifier=', 'label': 'D6970C00004\\_Redacted\\_CSR Synopsis'}, {'url': 'https://www.astrazenecaclinicaltrials.com/study/D6970C00004/', 'label': 'Results posted on AZCT.com'}]}, 'descriptionModule': {'briefSummary': "This study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive control, in healthy participants.", 'detailedDescription': 'This is a randomised, placebo-controlled, double-blind, 4-way crossover TQT study to assess the effect of single oral doses of baxdrostat on the QTcF compared to placebo using a concentration-QTcF analysis, and with open-label moxifloxacin as positive control, in 28 healthy participants, performed at a single clinical unit.\n\nThe study will comprise of:\n\n* a screening period of maximum 28 days,\n* four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing (Treatment Period Day 3).\n* a final Follow-up Visit within 7 to 10 days following discharge after Visit 5\n\nParticipants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods. Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4.\n\nTreatment Periods will be separated by a washout period of at least 7 days but no more than 9 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females must have a negative pregnancy test.\n* Have a Basal Metabolic index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg.\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* History of additional risk factors for Torsade de Pointes.\n* History of neoplastic disease.\n* Family history of sudden cardiac death.\n* Any skin condition likely to interfere with ECG electrode placement or adhesion.\n* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of drug.\n* Any clinically significant abnormalities at screening and first admission in rhythm, conduction, or morphology of the 12-lead resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the investigator.\n* Participant has clinical signs and symptoms consistent with COVID-19.\n* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.\n* Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the Clinical Unit.\n* Participants who have previously received Baxdrostat.\n* Participants with any special dietary restrictions such as participants who are lactose intolerant or are vegetarians/vegans.\n* Participants who cannot communicate reliably with the investigator and/or are not able to read, speak, and understand the local language.\n* Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.'}, 'identificationModule': {'nctId': 'NCT06194032', 'briefTitle': 'A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-Way Crossover Phase I Thorough QTc Study to Investigate the Effect on QTcF of Single Doses of Baxdrostat Compared With Placebo, Using Open-label Moxifloxacin as a Positive Control, in Healthy Participants', 'orgStudyIdInfo': {'id': 'D6970C00004'}, 'secondaryIdInfos': [{'id': '2023-506108-23-00', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ABCD', 'description': 'Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (ABCD) in a crossover design with a washout period of at least 7 days between each study dose administration.', 'interventionNames': ['Drug: Baxdrostat', 'Drug: Placebo', 'Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BDAC', 'description': 'Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (BDAC) in a crossover design with a washout period of at least 7 days between each study dose administration.', 'interventionNames': ['Drug: Baxdrostat', 'Drug: Placebo', 'Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CADB', 'description': 'Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (CADB) in a crossover design with a washout period of at least 7 days between each study dose administration.', 'interventionNames': ['Drug: Baxdrostat', 'Drug: Placebo', 'Drug: Moxifloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence DCBA', 'description': 'Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (DCBA) in a crossover design with a washout period of at least 7 days between each study dose administration.', 'interventionNames': ['Drug: Baxdrostat', 'Drug: Placebo', 'Drug: Moxifloxacin']}], 'interventions': [{'name': 'Baxdrostat', 'type': 'DRUG', 'description': 'Participants will receive baxdrostat as two separate doses.', 'armGroupLabels': ['Treatment Sequence ABCD', 'Treatment Sequence BDAC', 'Treatment Sequence CADB', 'Treatment Sequence DCBA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive baxdrostat matching placebo.', 'armGroupLabels': ['Treatment Sequence ABCD', 'Treatment Sequence BDAC', 'Treatment Sequence CADB', 'Treatment Sequence DCBA']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'description': 'Participants will receive a single dose moxifloxacin', 'armGroupLabels': ['Treatment Sequence ABCD', 'Treatment Sequence BDAC', 'Treatment Sequence CADB', 'Treatment Sequence DCBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}