A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood

Launched by BOEHRINGER INGELHEIM · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medicine called bosentan affects the levels of another medicine, nerandomilast, in the blood after a single dose. Researchers want to understand if bosentan changes how nerandomilast is processed in the body. This study is being done with healthy men, and it is an early phase trial, meaning it focuses on safety and how the medicines behave in the body.

To take part, men need to be between 18 and 55 years old, in good overall health, and have a body weight that fits within a healthy range. Participants will undergo a thorough health check before joining, including tests like blood pressure, heart rate, and blood tests to make sure they are healthy. During the study, participants will receive the medicines and have their blood tested to see how nerandomilast is affected by bosentan. This trial is not yet open for enrollment. It’s important to note that only healthy men without certain medical conditions or recent surgeries related to digestion can join, to ensure safety and accurate results.

Gender

MALE

Eligibility criteria

• Inclusion Criteria :
• • 1. Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), bodyweight, 12-lead electrocardiogram (ECG), and clinical laboratory tests
• • 2. Age of 18 to 55 years (inclusive)
• • 3. Body Mass Index (BMI) of 18.5 to 29.9 kg/ m² (inclusive)
• • 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• Exclusion Criteria :
• • 1. Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
• • 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• • 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• • 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• • 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
• • 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• • 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behaviour
• • 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.