Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-04 @ 5:42 AM
Study NCT ID:
NCT03535168
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1: Sequential parallel-group Part 2: Two-arm crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2018-05-14', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1', 'timeFrame': 'Approximately 5 weeks'}, {'measure': 'Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2', 'timeFrame': 'Approximately 12 weeks'}, {'measure': 'AUC of midazolam without BAY1902607', 'timeFrame': 'At Day -1', 'description': 'Part 1'}, {'measure': 'AUC of midazolam in combination with BAY1902607', 'timeFrame': 'At Day 13', 'description': 'Part 1'}, {'measure': 'Cmax of midazolam in combination with BAY1902607', 'timeFrame': 'At Day 13', 'description': 'Part 1'}, {'measure': 'Cmax of midazolam without BAY1902607', 'timeFrame': 'At Day -1', 'description': 'Part 1'}, {'measure': 'Number of Coughs Experienced by the Patient Within a 24-hour Period (24- hour cough count/hour) in Part 2', 'timeFrame': '24 hours', 'description': 'Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Cough']}, 'referencesModule': {'references': [{'pmid': '37041539', 'type': 'DERIVED', 'citation': 'Friedrich C, Francke K, Birring SS, van den Berg JWK, Marsden PA, McGarvey L, Turner AM, Wielders P, Gashaw I, Klein S, Morice AH. The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Respir Res. 2023 Apr 11;24(1):109. doi: 10.1186/s12931-023-02384-8.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}, {'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study:\n\n* To investigate the safety and tolerability of ascending repeated oral doses of BAY1902607 in healthy subjects (Part 1).\n* To investigate the effect of BAY1902607 on the pharmacokinetics (PK) of a sub-therapeutic 1 mg dose of midazolam (Part 1).\n* To investigate the safety, tolerability and efficacy of BAY1902607 in patients with refractory chronic cough (Part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1:\n\n* Male; healthy according to complete medical history, including the physical examination, vital signs (blood pressure, heart rate), 12-lead ECG, clinical laboratory tests\n* Age: 18-45 years (inclusive) at the first screening visit\n* Non-smoker for at least 6 months and with a pack year history of equal to or less than 5 years\n* Subjects, who are sexually active and have not been surgically sterilized, must agree to use two reliable and acceptable methods of contraception simultaneously, when having sexual intercourse with women of childbearing potential (one method used by the subject, one method used by the partner) during the study and for 90 days after receiving the investigational medicinal product, and not to act as sperm donor for 90 days after dosing. \\[Acceptable methods of contraception include for example: (a) condoms (male or female) with or without a spermicidal agent, (b) diaphragm or cervical cap with spermicide, (c) intrauterine device, (d) hormone-based contraception\\]\n\nPart 2:\n\n* Age: ≥18 years at the first screening visit\n* Refractory chronic cough for at least one year that has been shown to be unresponsive to treatment of cough according to the 2006 British Thoracic Society (BTS) guideline\n* Score of ≥ 40 mm on the Cough Severity visual analogue scale (VAS) at screening\n* For female patients:\n\nConfirmed post-menopausal woman (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone (FSH) levels \\> 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at least 6 weeks before screening, such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification) or Woman of childbearing potential that agrees to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for at least 31 days (1 average menstrual cycle of 28 days plus approx. 5 half-lives of BAY 1902607) after the last dose. In addition during the study and for at least 31 days after the last dose women of child bearing potential are not allowed to donate oocytes.\n\nExclusion Criteria:\n\nPart 1:\n\n* Relevant diseases potentially interfering with the study objectives (e.g. respiratory diseases) within the four weeks before screening or between screening and randomization\n* Any febrile illness within the four weeks before screening or between screening and randomization\n* Medical history of hypogeusia/dysgeusia or the subject has a dysfunction in his ability to taste, as revealed by the taste-disturbance questionnaire during screening and the predose procedures\n\nPart 2:\n\n* FEV1(Forced Expiratory Volume in 1 second) or FVC(Forced Vital Capacity ) of less than 60% of predicted normal, at screening\n* History of upper or lower respiratory tract infection or recent significant change in pulmonary status within the 4 weeks before screening\n* Current smoking habit or history of smoking within the 6 months before the screening visit\n* History of smoking (at any time) for more than 20 pack-years in total (20 cigarettes per pack)'}, 'identificationModule': {'nctId': 'NCT03535168', 'briefTitle': 'Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Two-part, Double-blind, Placebo-controlled, Randomized, Parallel-group Study: (Part 1) in Healthy Male Subjects to Assess Safety and Tolerability of Ascending Repeated Oral Doses of BAY1902607 Including Its Effect on the Pharmacokinetics of a Sub-therapeutic Dose of Midazolam (MDZ), Followed by (Part 2) a Two-way Crossover Administration of Four Different Doses of BAY1902607 in Patients With Refractory Chronic Cough to Assess Safety, Tolerability and Efficacy for Proof of Concept', 'orgStudyIdInfo': {'id': '19430'}, 'secondaryIdInfos': [{'id': '2018-000129-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 of BAY1902607', 'description': 'Part 1: From Day 1 until Day 12 the dose 1 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 1 of BAY1902607 will be given only once.', 'interventionNames': ['Drug: BAY1902607', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 of BAY1902607', 'description': 'Part 1: From Day 1 until Day 12 the dose 2 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 2 of BAY1902607 will be given only once.', 'interventionNames': ['Drug: BAY1902607', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 of BAY1902607', 'description': 'Part 1: From Day 1 until Day 12 the dose 3 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 3 of BAY1902607 will be given only once.', 'interventionNames': ['Drug: BAY1902607', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'Matching placebo', 'description': 'Part 1: From Day 1 until Day 12 the matching placebo will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, matching placebo will be given only once.', 'interventionNames': ['Drug: Matching placebo', 'Drug: Midazolam']}, {'type': 'EXPERIMENTAL', 'label': 'BAY1902607+Matching Placebo', 'description': 'Part 2:\n\nRandomized crossover design in cough patients 4 different doses of BAY1902607+matching placebo', 'interventionNames': ['Drug: BAY1902607', 'Drug: Matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Matching Placebo+BAY1902607', 'description': 'Part 2:\n\nRandomized crossover design in cough patients Matching placebo+4 different doses of BAY1902607', 'interventionNames': ['Drug: BAY1902607', 'Drug: Matching placebo']}], 'interventions': [{'name': 'BAY1902607', 'type': 'DRUG', 'description': '3 different doses over the course of part 1 and 4 different doses over the course of part 2.', 'armGroupLabels': ['BAY1902607+Matching Placebo', 'Dose 1 of BAY1902607', 'Dose 2 of BAY1902607', 'Dose 3 of BAY1902607', 'Matching Placebo+BAY1902607']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Matching placebo for BAY1902607', 'armGroupLabels': ['BAY1902607+Matching Placebo', 'Matching Placebo+BAY1902607', 'Matching placebo']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning.', 'armGroupLabels': ['Dose 1 of BAY1902607', 'Dose 2 of BAY1902607', 'Dose 3 of BAY1902607', 'Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': 'BT9 7BL', 'city': 'Belfast', 'state': 'Antrim', 'country': 'United Kingdom', 'facility': "Queen's University", 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital - NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9GP', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University Hospital of South Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}