RecruitingPhase 1NCT06916702
A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Sponsor
Boehringer Ingelheim
Enrollment
60 participants
Start Date
Apr 7, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 50 Years
Inclusion Criteria4
- 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 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
- 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 Criteria4
- Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 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
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Interventions
DRUGBI 3031185
BI 3031185
DRUGMidazolam
Midazolam
DRUGPlacebo
Placebo matching BI 3031185
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06916702
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