This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thro

• Status: Recruiting
• Trial end date: 2023-11-06
• Target enrollment: 0
• Participant gender: All

Summary

In this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure affecting the blood vessels in the lungs 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 patients stably pretreated with specific PH drugs will be studied in combination with the new inhaled drug

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

Main Inclusion Criteria:

• Patients with PAH or CTEPH undergoing medically indicated routine invasive diagnostics

• Men and women aged 18 to 80 years

Part A:

• Untreated patients: Therapy-naive patients (defined as off treatment with PDE-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sGC stimulators/activators with PAH or CTEPH or patients pretreated with approved or specific medication for PH like endothelin antagonists, prostanoids, phosphodiesterase type 5 inhibitor (PDE5 I) or soluble guanylate cyclase (sGC) stimulators who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 hours prior to Day -1 if medically safe.

Part B:

• Untreated patients with PAH or CTEPH:

-- Group 1 (total will be summed up with corresponding dosage group from Part A)

• Pre-treated patients with PAH or CTEPH:

• Group 2: Pre-treated patients with any kind of monotherapy* for PAH/CTEPH

• Group 3: Pre-treated patients with any kind of double combination therapy* for PAH/CTEPH * patients receiving inhaled Iloprost, and patients who are known responders to iNO are excluded

Main Exclusion Criteria:

• Medical history indicating a different cause for PH than PAH or CTEPH according to the guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease

• History of or current possible or verified COVID-19 infection