Not Yet RecruitingPhase 1

A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People

Belgium136 participantsStarted 2026-05-18

Plain-language summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age of 18 to 65 years (inclusive) at the time of screening
✓. Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
✓. 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
✓. 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.
✓. Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.

Exclusion criteria

✕. 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
✕. 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)
✕. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
✕. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.

What they're measuring

Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator

Timeframe: up to 111 days

Trial details

NCT IDNCT07486115

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-12

Contact for this trial

Boehringer Ingelheim

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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