Phase
Condition
N/ATreatment
BI 3731579
Clinical Study ID
Ages 18-50 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Healthy male subjects according to the assessment of the investigator, as based on acomplete medical history including a physical examination, vital signs (bloodpressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinicallaboratory 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 Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial
Exclusion
Exclusion criteria:
Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal 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 outsidethe range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator Further exclusion criteria apply.
Study Design
Connect with a study center
Humanpharmakologisches Zentrum Biberach
Biberach, 88397
GermanySite Not Available
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