RecruitingPhase 1

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

Germany100 participantsStarted 2025-04-07

Plain-language summary

Part A: 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. Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests * Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive) * Part A: 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 * Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential): * Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) * Postmenopausal, defined as no menses for at least 1 year without an alternative medical cause. In questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory * Further inclusion criteria apply Exclusion Criteria: * Any finding in the medical examination (inclu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

Timeframe: Up to Day 54

Trial details

NCT IDNCT06916702

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-07

Contact for this trial

Boehringer Ingelheim

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

View on ClinicalTrials.gov More Healthy trials