In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B also patients stably pre-treated with specific PH drugs will be studied in combination with the new inhaled drug
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
38
Oral inhalation with dry powder inhaler, single dose.
Medizinische Universität Graz
Graz, Austria
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, Czechia
Krankenhaus Neuwittelsbach
München, Bavaria, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
Universitätsklinikum Giessen und Marburg
Giessen, Hesse, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Szpital Specjalistyczny im. Jana Pawla II
Krakow, Poland
Peak percent reduction in PVR (Pulmonary vascular resistance) from "baseline 2" for untreated patients
PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5) * PAP = pulmonary arterial pressure * PCWP = pulmonary capillary wedge pressure * CO = cardiac output
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline 2"
Peak percent reduction in PVR from "baseline" for pre-treated patients
PVR = 80\* (PAP - PCWP) / CO (dyn·sec·cm-5)
Time frame: Up to 5 hours post inhalation of BAY1237592 compared to "baseline"
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 7 days after treatment
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