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Completed
NCT06861829
A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood
Conditions: Healthy
Sex: Male
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 12
Sponsor: Boehringer Ingelheim
Location: Humanpharmakologisches Zentrum Biberach Biberach
Summary
This trial investigates whether food influences the amount of BI 3731579 in the blood.
Eligibility Criteria
Inclusion criteria:
* Healthy male subjects 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 18 to 50 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
Exclusion criteria:
* Any finding in the medical examination (including BP, PR or 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 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 Further exclusion criteria apply.
Source: ClinicalTrials.gov (NCT06861829). StuddyBuddy aggregates publicly available trial information.