Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 1:07 PM
Study NCT ID:
NCT02479204
Status:
TERMINATED
Last Update Posted:
2025-09-22
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lymphocyte count as a measure of immunomodulation (Part A + Part B)', 'timeFrame': 'Day 1, Day 6, Day 12 and Day 20 (Part A); Day 1 and Day 8 toDay 16 (Part B)'}], 'primaryOutcomes': [{'measure': 'PR intervals measured by 12-lead ECG (Part A + Part B)', 'timeFrame': 'Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)', 'description': 'Absolute PR intervals and corresponding changes from baseline at the different days of measurement'}, {'measure': 'Heart rate (HR) measured by 12-lead ECG (PArt A + Part B)', 'timeFrame': 'Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)', 'description': 'Absolute heart rates at the different days of measurement'}, {'measure': 'Hourly mean heart rate (HR) measured by 24-hour Holter ECG', 'timeFrame': 'Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B', 'description': 'Absolute and change from baseline in hourly mean HR on each day of measurement'}], 'secondaryOutcomes': [{'measure': 'Areas under the plasma concentration-time curves (AUC) for ACT-334441, diltiazem and atenolol (Part B)', 'timeFrame': 'Blood samples from Day 1 to Day 20 for the PK profile of diltiazem and atenolol, and from Day 8 to Day 21 for the PK profile of ACT-334441.', 'description': 'AUCs will be calculated will be calculated according to the linear trapezoidal rule for the following periods: from zero to time t of the last measured concentration above the limit of quantification, from zero to 24h after study drug administration, from zero to infinity)'}, {'measure': 'Maximum plasma concentration (Cmax) for ACT-334441, diltiazem and atenolol (Part B)', 'timeFrame': 'From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444.', 'description': 'The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective Cmax'}, {'measure': 'Time to reach the maximum plasma concentration (tmax) for ACT-334441, diltiazem and atenolol (Part B)', 'timeFrame': 'From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444', 'description': 'The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective tmax'}, {'measure': 'Terminal half-life [t(1/2)] of ACT-334441, diltiazem and atenolol (Part B)', 'timeFrame': 'From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444', 'description': 'Time required for the plasma concentration of a drug to decrease by 50% in the final stage of its elimination'}, {'measure': 'Trough plasma levels (Ctrough) of of ACT-334441, diltiazem and atenolol (Part B)', 'timeFrame': 'From Day 1 to Day 15 for diltiazem and atenolol; from Day 8 to Day 15 for ACT-33444', 'description': 'Ctrough will be used to determine the attainment of steady state conditions'}, {'measure': 'Number of subjects with adverse events as a measure of safety', 'timeFrame': 'From baseline to end of study [Day 20-23 (Part A), Day 556-59 (Part B)]', 'description': 'An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom or disease, that occurs during the course of the study, whether or not considered related to the study drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'heart rate', 'pharmacokinetics'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.', 'detailedDescription': 'The study will consist of two parts: a pilot part (Part A) that will be completed prior to the start of the main part (Part B). The Subjects who will participate in Part A are excluded from Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.\n* Women of childbearing potential must have a negative pregnancy test and they must use reliable methods of contraception\n* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Any contraindication to the study drugs\n* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs\n* Any clinically significant abnormalities in laboratory tests, vital signs, ECG variables and pulmonary variables\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT02479204', 'briefTitle': 'Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Single-center, Open-label, Randomized, Multiple-dose, Parallel-group Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 Combined With Calcium-channel Blocker (Diltiazem) or Beta-blocker (Atenolol) Treatment in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AC-064-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A ACT-334441 + atenolol', 'description': '4 subjects will receive 50 mg of atenolol once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6', 'interventionNames': ['Drug: ACT-334441 2 mg', 'Drug: Atenolol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A ACT-334441 + diltiazem', 'description': '4 subjects will receive 240 mg of diltiazem once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6', 'interventionNames': ['Drug: ACT-334441 2 mg', 'Drug: Diltiazem ER']}, {'type': 'EXPERIMENTAL', 'label': 'Part B ACT-334441 + atenolol', 'description': '12 subjects will receive 50 mg of atenolol (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15', 'interventionNames': ['Drug: ACT-334441 4 mg', 'Drug: Placebo', 'Drug: Atenolol']}, {'type': 'EXPERIMENTAL', 'label': 'Part B ACT-334441 + diltiazem', 'description': '12 subjects will receive 240 mg of diltiazem (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15', 'interventionNames': ['Drug: ACT-334441 4 mg', 'Drug: Placebo', 'Drug: Diltiazem ER']}], 'interventions': [{'name': 'ACT-334441 2 mg', 'type': 'DRUG', 'description': 'capsule containing ACT-334441 at a strength of 2 mg', 'armGroupLabels': ['Part A ACT-334441 + atenolol', 'Part A ACT-334441 + diltiazem']}, {'name': 'ACT-334441 4 mg', 'type': 'DRUG', 'description': 'capsule containing ACT-334441 at a strength of 4 mg', 'armGroupLabels': ['Part B ACT-334441 + atenolol', 'Part B ACT-334441 + diltiazem']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'ACT-33441-matching placebo', 'armGroupLabels': ['Part B ACT-334441 + atenolol', 'Part B ACT-334441 + diltiazem']}, {'name': 'Atenolol', 'type': 'DRUG', 'otherNames': ['Tenormine'], 'description': 'film-coated tablet containing atenolol at a strength of 50 mg', 'armGroupLabels': ['Part A ACT-334441 + atenolol', 'Part B ACT-334441 + atenolol']}, {'name': 'Diltiazem ER', 'type': 'DRUG', 'otherNames': ['Bi-tildiem'], 'description': 'film-coated tablet containing diltiazem at a strength of of 120 mg', 'armGroupLabels': ['Part A ACT-334441 + diltiazem', 'Part B ACT-334441 + diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CS 34246', 'city': 'Rennes', 'country': 'France', 'facility': 'BIOTRIAL', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Viatris Innovation GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viatris Innovation GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}