Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07649941

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

Conditions: Healthy

Sex: Male
Ages: 25 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 16
Sponsor: Boehringer Ingelheim

Location: Humanpharmakologisches Zentrum Biberach Biberach

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07649941). StuddyBuddy aggregates publicly available trial information.