A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age25-55
SponsorBoehringer Ingelheim
About this trial
The main objective of this trial is to investigate the effect of a moderate CYP 3A inducer bosentan on the pharmacokinetics of zongertinib.
Eligibility criteria
Qualifiers
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
Age of 25 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
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
Disqualifiers
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
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
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Trial design
Treatments tested in this trial
- Zongertinib
- Bosentan
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov