Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05500820
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2022-08-12', 'studyFirstSubmitQcDate': '2022-08-12', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit.'}, {'measure': 'Time to maximum plasma concentration (Tmax)', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first and last doses of CIN-107, as the data permit.'}, {'measure': 'Area under the curve from time 0 to the time of last quantifiable plasma concentration (AUC[0-last])', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.'}, {'measure': 'Area under the curve from time 0 to infinity', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.'}, {'measure': 'Area under the curve over a dosing interval (tau)', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.'}, {'measure': 'Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours', 'timeFrame': 'up to Day 2', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data and following the first dose of CIN-107, as the data permit.'}, {'measure': 'Percent of AUC extrapolated', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.'}, {'measure': 'Terminal phase elimination half-life', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data following the final dose of CIN-107, as the data permit.'}, {'measure': 'Apparent plasma clearance', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be determined for CIN-107 using plasma concentration data.'}, {'measure': 'Apparent volume of distribution', 'timeFrame': 'Up to Day 15', 'description': 'This PK parameter will be determined for CIN-107 using plasma concentration data.'}, {'measure': 'The cumulative amount of CIN-107 and CIN-107-M excreted in the urine (Ae)', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)'}, {'measure': 'Renal clearance (CLR Calculated as Ae/AUC) of CIN-107 and CIN-107-M', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)'}, {'measure': 'Fraction of the dose excreted renally (fe)', 'timeFrame': 'up to Day 15', 'description': 'This PK parameter will be calculated using the urine concentrations of CIN-107'}, {'measure': 'Number of patients experiencing adverse events (AEs)', 'timeFrame': 'up to Day 15'}, {'measure': 'Number of patients experiencing adverse drug reactions', 'timeFrame': 'up to Day 15'}, {'measure': 'Number of patients experiencing serious adverse events (SAEs)', 'timeFrame': 'up to Day 15'}, {'measure': 'Plasma concentration of aldosterone', 'timeFrame': 'up to Day 15'}, {'measure': 'Plasma renin activity', 'timeFrame': 'up to Day 15'}, {'measure': 'Plasma concentration of cortisol (free and total)', 'timeFrame': 'up to Day 15'}, {'measure': 'Plasma concentration of ACTH (Adrenocorticotropic hormone)', 'timeFrame': 'up to Day 15'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetics (PK), metabolism, baxdrostat'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '36266539', 'type': 'BACKGROUND', 'citation': 'Freeman MW, Bond M, Murphy B, Hui J, Isaacsohn J. Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Hypertens Res. 2023 Jan;46(1):108-118. doi: 10.1038/s41440-022-01070-4. Epub 2022 Oct 20.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-111&attachmentIdentifier=5ae8edfe-848e-4a91-ad8a-ff0a5e360aae&fileName=cin-107-111-report-synopsis_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, study to assess the safety, tolerability, PK, and PD of multiple oral doses of CIN-107 when administered to healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, ECG, orthostatic vital signs, and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis).\n2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.\n3. Nonsmokers who have not used nicotine-containing products for at least 6 months prior to the Screening Visit.\n\nExclusion Criteria:\n\n1. Actively participating in an experimental therapy study; received experimental therapy with a small molecule within 30 days of Day 1, or 5 half-lives, whichever is longer; or received experimental therapy with a large molecule within 90 days of Day 1, or 5 half-lives, whichever is longer.\n2. A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.\n3. History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, or atrial fibrillation.\n4. Prolonged QTcF (\\>450 msec) based on the average of triplicate ECGs.\n5. Seated blood pressure higher than 150/90 mmHg or lower than 90/50 mmHg.\n6. Resting heart rate higher than 100 bpm or lower than 50 bpm , sinus node dysfunction, or clinically significant heart block.\n7. Temperature (T) greater than 37.6o C (99.68o F, measured orally), and respiration rate less than 12 and greater than 20 breaths/minute.\n8. Postural tachycardia (ie \\>30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic blood pressure (SBP) of ≥20 mm Hg or DBP of ≥ 10 mm Hg when a person assumes a standing position).\n9. Serum potassium \\> upper limit of normal of the reference range (ULN) and serum sodium \\< lower limit of normal of the reference range (LLN).\n10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values \\> 1.2 ULN.\n11. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).\n12. A known history of porphyria, myopathy, or an active liver disease.\n13. Positive drug or alcohol test result or a history of alcoholism or drug abuse within 2 years prior to the first dose of study drug as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition: DSM-IV.\n14. Typical consumption of ≥14 alcoholic drinks weekly.\n15. Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.\n16. Currently undergoing treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery).\n17. Pregnant, breastfeeding, or planning to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT05500820', 'briefTitle': 'Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CIN-107 Following Multiple Oral Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CIN-107-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: 2.5 mg CIN-107', 'description': 'Subjects on a low salt diet', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: 5.0 mg CIN-107', 'description': 'Subjects on a low salt diet', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: 1.5 mg CIN-107', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: 2.5 mg CIN-107', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: 0.5 mg CIN-107', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: CIN-107']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 1: 2.5 mg matching placebo', 'description': 'Subjects on a low salt diet', 'interventionNames': ['Drug: Matching Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 2: 5.0 mg matching placebo', 'description': 'Subjects on a low salt diet', 'interventionNames': ['Drug: Matching Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 3: 1.5 mg matching placebo', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: Matching Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 4: 2.5 mg matching placebo', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: Matching Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 5: 0.5 mg matching placebo', 'description': 'Subjects on a normal salt diet', 'interventionNames': ['Drug: Matching Placebo']}], 'interventions': [{'name': 'CIN-107', 'type': 'DRUG', 'otherNames': ['baxdrostat'], 'description': 'A repeat oral dose of CIN-107 once daily for 10 days.', 'armGroupLabels': ['Cohort 1: 2.5 mg CIN-107', 'Cohort 2: 5.0 mg CIN-107', 'Cohort 3: 1.5 mg CIN-107', 'Cohort 4: 2.5 mg CIN-107', 'Cohort 5: 0.5 mg CIN-107']}, {'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'A repeat oral dose of matching placebo once daily for 10 days.', 'armGroupLabels': ['Cohort 1: 2.5 mg matching placebo', 'Cohort 2: 5.0 mg matching placebo', 'Cohort 3: 1.5 mg matching placebo', 'Cohort 4: 2.5 mg matching placebo', 'Cohort 5: 0.5 mg matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Leela Vrishabhendra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medpace Clinical Pharmacology Unit'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], '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\n\nVivli.org. All requests will be evaluated as per the AZ disclosure commitment:\n\nhttps://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'}}}}