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

Active Not RecruitingPhase 1

Sponsor: Boehringer Ingelheim

Conditions: Healthy

Interventions: Zongertinib, Bosentan

Countries: Germany

The main objective of this trial is to investigate the effect of a moderate CYP 3A inducer bosentan on the pharmacokinetics of zongertinib.

Eligibility overview

Sex: MALE

Age: 25 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
2. Age of 25 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 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 (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 (PR) 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. Further exclusion criteria apply.

Locations (1)

Biberach, Germany