A Phase 1/2 interventional study of BAY1902607 and Matching placebo in Cough, sponsored by Bayer. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Bayer · Phase 1/2, Interventional, and Treatment
The primary objectives of this study:
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 59 is below the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Part 1:
Part 2:
Confirmed 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.
Exclusion Criteria:
Part 1:
Part 2:
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.
Drug: BAY1902607 · Drug: Midazolam
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.
Drug: BAY1902607 · Drug: Midazolam
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.
Drug: BAY1902607 · Drug: Midazolam
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.
Drug: Matching placebo · Drug: Midazolam
Part 2: Randomized crossover design in cough patients 4 different doses of BAY1902607+matching placebo
Drug: BAY1902607 · Drug: Matching placebo
Part 2: Randomized crossover design in cough patients Matching placebo+4 different doses of BAY1902607
Drug: BAY1902607 · Drug: Matching placebo
3 different doses over the course of part 1 and 4 different doses over the course of part 2.
Matching placebo for BAY1902607
Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning.
Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1
Time frame: Approximately 5 weeks
Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2
Time frame: Approximately 12 weeks
AUC of midazolam without BAY1902607
Part 1
Time frame: At Day -1
AUC of midazolam in combination with BAY1902607
Part 1
Time frame: At Day 13
Cmax of midazolam in combination with BAY1902607
Part 1
Time frame: At Day 13
Cmax of midazolam without BAY1902607
Part 1
Time frame: At Day -1
Number of Coughs Experienced by the Patient Within a 24-hour Period (24- hour cough count/hour) in Part 2
Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph)
Time frame: 24 hours
Plan to share: No — 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.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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