💬In plain words
What the trial is, and whether it could suit you
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion criteria:
1. Age of 18 to 65 years (inclusive) at the time of screening
2. Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
3. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
4. Agree to refrain from strenuous or unusual exercise/activity (for example heavy lifting, weight training, intense aerobics classes, etc.) for at least 72 hours prior to study visits.
5. Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.
Further inclusion criteria apply.
Exclusion criteria:
1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.
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