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NCT05723874
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
Conditions: Healthy
Sex: Male
Ages: 30 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 14
Sponsor: Boehringer Ingelheim
Summary
The main objective of this trial is to investigate the relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.
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 testsAge of 30 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 trialExclusion Criteria:Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigatorRepeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 45 to 90 beats per minute (bpm)Any laboratory value outside the reference range that the investigator considers to be of clinical relevanceAny evidence of a concomitant disease assessed as clinically relevant by the investigatorGastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disordersCholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disordersHistory of relevant orthostatic hypotension, fainting spells, or blackoutsFurther exclusion criteria apply
Source: ClinicalTrials.gov (NCT05723874). StuddyBuddy aggregates publicly available trial information.