Testing Different Doses of BI 3814916 for Safety in Healthy Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial investigates safety, tolerability, and pharmacokinetics of BI 3814916 across multiple dose levels in healthy adult volunteers. It uses a randomized, placebo-controlled design to compare active drug with placebo. Participants are healthy individuals aged 18–65 with specific BMI ranges, who must refrain from strenuous activity and alcohol or soft drugs around study visits. Exclusion criteria include clinically abnormal medical findings and vital sign abnormalities. Lead Sponsor is Boehringer Ingelheim, with the study conducted at SGS Life Science Services in Edegem.

Why it matters

Who can join: the full rules

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.

Where it's running

• SGS Life Science Services - Clinical Research
  Edegem, Belgium Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.