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

An Open-label, Fixed-sequence, Two-period Phase I Trial to Evaluate the Effect of Multiple Oral Doses of Carbamazepine, a Strong CYP3A4 Inducer, on the Pharmacokinetics of Verducatib at Steady State in Healthy Male Trial Participants

The main objective of this trial is to investigate the effect of carbamazepine, a strong CYP3A4 inducer on the pharmacokinetics of verducatib at steady state.

Inclusion Criteria:

1. Healthy male trial participant according to the assessment of the Investigator, as based on a complete medical history including physical examination, vital signs (blood pressure, heart rate), 12-lead electrocardiogram, clinical laboratory tests and columbia-suicide severity rating scale (C-SSRS)
2. Age of 18 to 50 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 international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination, including blood pressure, pulse rate or electrocardiogram, as well as 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 outside the range of 50 to 90 beats per minute
3. Any laboratory value outside the reference range that the Investigator considers to be of clinical relevance, particularly including but not limited to haematological parameters such as haemoglobin, serum iron, leucocyte- and platelet count, hepatic parameters such as alanine aminotransferase (ALT), aspartate aminotransfrrase (AST), gamma-glutamyl transferase (GGT) and total bilirubin or renal parameters such as e.g. creatinine at screening, electrolyte disturbances, particularly hyponatremia
4. Any evidence of a concomitant disease assessed as clinically relevant by the Investigator
5. Further exclusion criteria apply