A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood

Launched by BOEHRINGER INGELHEIM · Jul 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called carbamazepine affects the amount of another drug, nerandomilast, in the blood. The goal is to understand how these two medicines interact in healthy men. This is an early phase study, which means it focuses on safety and how the body processes the drugs, rather than treating a disease.

Men between 18 and 55 years old who are in good health may be eligible to join. To qualify, participants will need to have a normal health check-up, including tests for blood pressure, heart rate, body weight, and heart function. If sexually active, they should use contraception or abstain from sex for a short time after taking carbamazepine. During the study, participants will be closely monitored to ensure their safety. This trial is not yet open for recruiting volunteers, so those interested should watch for updates from the study center.

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)), body weight, 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/ m\^2 (inclusive)
• • 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• • 5. If sexually active, sexual abstinence or use of a condom for at least 2 weeks after the last administration of carbamazepine.
• Exclusion Criteria :
• • 1. Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or ECG, neurological examination and skin inspection) 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 (PR) outside the range of 50 to 90 bpm
• • 3. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• • 4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological, neurological, psychiatric or hormonal disorders assessed as clinically relevant by the investigator
• • 5. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• • 6. 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
• • 7. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.