NCT07486115 A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy People
| NCT ID | NCT07486115 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2026-05-20 |
| Primary Completion | 2027-07-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 136 participants in total. It began in 2026-05-20 with a primary completion date of 2027-07-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07486115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07486115 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07486115 currently recruiting?
Yes, NCT07486115 is actively recruiting participants. Contact the research team at clintriage.rdg@boehringer-ingelheim.com for enrollment information.
Where is the NCT07486115 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT07486115 clinical trial?
NCT07486115 is sponsored by Boehringer Ingelheim. The trial plans to enroll 136 participants.