The primary objectives of this study: * To investigate the safety and tolerability of ascending repeated oral doses of BAY1902607 in healthy subjects (Part 1). * To investigate the effect of BAY1902607 on the pharmacokinetics (PK) of a sub-therapeutic 1 mg dose of midazolam (Part 1). * To investigate the safety, tolerability and efficacy of BAY1902607 in patients with refractory chronic cough (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
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.
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Isala
Zwolle, Netherlands
Queen's University
Belfast, Antrim, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom
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
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Castle Hill Hospital
Cottingham, United Kingdom
King's College Hospital - NHS Foundation Trust
London, United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom
University Hospital of South Manchester
Manchester, United Kingdom