To investigate the safety and tolerability of ascending repeated oral doses of BAY1817080 in healthy volunteers(Part1). To investigate the safety, tolerability and efficacy of BAY1817080 in patients with refractory chronic cough(Part2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
4 different doses over the course of study
Matching placebo for BAY1817080
North Tyneside General Hospital
North Shields, Tyne and Wear, United Kingdom
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom
Queen's University
Belfast, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Frequency of treatment emergent adverse events in study part 1
Time frame: Up to 5 weeks
Severity of treatment emergent adverse events in study 1
The intensity of an AE is classified according to the following categories: * Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. * Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. * Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status
Time frame: Up to 5 weeks
Frequency of treatment emergent adverse events in study part 2
Time frame: Up to 12 weeks
Severity of treatment emergent adverse events in study part 2
The intensity of an AE is classified according to the following categories: * Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. * Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. * Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status
Time frame: Up to 12 weeks
24-hour cough counts
Time frame: At week 1 in period A
24 hour cough counts
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King's College Hospital - NHS Foundation Trust
London, United Kingdom
University Hospital of South Manchester
Manchester, United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom
Time frame: At week 2 in period A
24 hour cough counts
Time frame: At week 3 in period A
24 hour cough counts
Time frame: At week 1 in period B
24 hour cough counts
Time frame: At week 2 in period B
24 hour cough counts
Time frame: At week 3 in period B