Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-26 @ 12:06 PM
Study NCT ID:
NCT02264002
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, Compared to Metoprolol Succinate and Placebo in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C490484', 'term': 'cilobradine'}, {'id': 'D008790', 'term': 'Metoprolol'}], '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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-13', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-13', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in heart rate at rest', 'timeFrame': 'Pre-dose, up to day 20 after first drug administration'}, {'measure': 'Changes in heart rate during exercise', 'timeFrame': 'Pre-dose, up to day 20 after first drug administration'}, {'measure': 'Changes in flicker fusion frequency test (FFF)', 'timeFrame': 'Pre-dose, up to day 20 after first drug administration'}], 'secondaryOutcomes': [{'measure': 'Number of patients with clinically relevant changes in laboratory tests', 'timeFrame': 'Pre-dose, up to 12 days after last drug administration'}, {'measure': 'Number of patients with clinically relevant changes in vital signs (blood pressure, heart rate)', 'timeFrame': 'Pre-dose, up to 12 days after last drug administration'}, {'measure': 'Number of patients with clinically relevant changes in 12-lead ECG', 'timeFrame': 'Pre-dose, up to 12 days after last drug administration'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 12 days after last drug administration'}, {'measure': 'Assessment of global tolerability by the investigator', 'timeFrame': 'Up to 12 days after last drug administration'}, {'measure': 'Changes in peripheral FFF', 'timeFrame': 'Pre-dose, up to day 20 after first drug administration'}, {'measure': 'Area under the concentration-time curve of the analytes in plasma (AUC)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Maximum measured concentration of the analytes in plasma (Cmax)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Time from dosing to the maximum concentration of the analytes in plasma (tmax)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Terminal half-life of the analytes in plasma (t½)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Mean residence time of the analytes in the body after oral administration (MRTpo)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Total clearance of the analytes in plasma following extravascular administration (CL/F)', 'timeFrame': 'Up to day 20 after start of first drug administration'}, {'measure': 'Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)', 'timeFrame': 'Up to day 20 after start of first drug administration'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Pharmacodynamic effects on heart rate (HR) at rest and during exercise and on flicker fusion frequency (FFF), FFF method evaluation\n\nSafety, tolerability and pharmacokinetics of cilobradine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants in the study should be healthy males and females. Volunteers will\n\n * be 21 to 55 years of age\n * have a Body Mass Index (BMI) of 19.9 to 29.9 kg/m2 and\n * have a resting heart rate (HR) (after 10 min. in the supine position) of more than 55 beats per minute (bpm)\n* Only post-menopausal females, or those who had had a hysterectomy, could participate. All females had to have a negative pregnancy test\n* In accordance with good clinical practice (GCP) and the local legislation all volunteers had to give their written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system or psychiatric disorders or neurological disorders\n* History of relevant orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the Investigator\n* Intake of drugs with a long half-life (\\> 24 hours) within ten half-lives of the respective drug before enrolment in the study\n* Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial\n* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)\n* Smoker (\\> 10 cigarettes or \\> 3 cigars of \\> 3 pipes/day)\n* Inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g/day)\n* Drug abuse\n* Blood donation (≥ 100 ml within four weeks prior to administration or during the trial)\n* Excessive physical activities (within the last week before the study)\n* Any laboratory value outside the reference range of clinical relevance\n\nNot necessarily clinically relevant abnormalities, but specific Exclusion criteria for the drugs under study or for the study:\n\n* Consumption of more than 2 cups of coffee or black tea, or cola drinks, per day during the last 6 weeks. However, subjects may participate if abstinence from the before mentioned beverages is well tolerated during an interval of at least 2 weeks between screening and first treatment\n* ECG: PQ interval \\> 210 ms\n* HR at rest \\< 55 bpm\n* Systolic BP \\< 115 mmHg\n* Colour vision test abnormal. However, subjects may participate if they are able to perform the flicker fusion test without difficulty\n* Psoriasis (own medical history or relative)\n* Relevant ophthalmological disease\n* History of asthma or obstructive pulmonary disease\n* History (including childhood) of traumatic injury to the head or brain\n* History (including childhood) of reduced seizure threshold\n* The following subjects will not be allowed to participate in the study\n\n * Any subject involved in professional transportation of human subjects\n * Any subject involved in operating dangerous machinery'}, 'identificationModule': {'nctId': 'NCT02264002', 'briefTitle': 'Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, Compared to Metoprolol Succinate and Placebo in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Pharmacodynamic Effects, Safety and Tolerability of 0.25 mg, 0.5 mg, 1 mg and 2 mg Cilobradine, Compared to 190 mg Metoprolol Succinate and Placebo, Administered p.o. Once Daily Over 14 Days to Healthy Volunteers in a Randomised, Placebo-controlled, Partly Double Blind Study, With a 4 mg/14 mg and 10 mg/20 mg Cilobradine Single Dose Versus Placebo Substudy (Double Blind, Three-fold Cross-over)', 'orgStudyIdInfo': {'id': '503.203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cilobradine low dose 1', 'interventionNames': ['Drug: Cilobradine low dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Cilobradine low dose 2', 'interventionNames': ['Drug: Cilobradine low dose 2']}, {'type': 'EXPERIMENTAL', 'label': 'Cilobradine medium dose', 'interventionNames': ['Drug: Cilobradine medium dose']}, {'type': 'EXPERIMENTAL', 'label': 'Cilobradine high dose 1', 'interventionNames': ['Drug: Cilobradine high dose 1']}, {'type': 'EXPERIMENTAL', 'label': 'Cilobradine high dose 2', 'interventionNames': ['Drug: Cilobradine high dose 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metoprolol succinate', 'description': '1 tablet on day 1, day 2 followed by two tablets from day 3 to day 14', 'interventionNames': ['Drug: Metoprolol succinate tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cilobradine low dose 1', 'type': 'DRUG', 'armGroupLabels': ['Cilobradine low dose 1']}, {'name': 'Cilobradine low dose 2', 'type': 'DRUG', 'armGroupLabels': ['Cilobradine low dose 2']}, {'name': 'Cilobradine medium dose', 'type': 'DRUG', 'armGroupLabels': ['Cilobradine medium dose']}, {'name': 'Cilobradine high dose 1', 'type': 'DRUG', 'armGroupLabels': ['Cilobradine high dose 1']}, {'name': 'Cilobradine high dose 2', 'type': 'DRUG', 'armGroupLabels': ['Cilobradine high dose 2']}, {'name': 'Metoprolol succinate tablets', 'type': 'DRUG', 'armGroupLabels': ['Metoprolol succinate']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}