Testing the safety and tolerability of BI 3031185 in healthy men
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
This study is testing a new drug called BI 3031185 in healthy men to see if it's safe and how well their bodies handle it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06916702 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the safety, tolerability, and pharmacokinetics of BI 3031185 by administering multiple rising doses to healthy male participants. The study will involve a thorough medical assessment, including physical examinations and laboratory tests, to ensure participants meet the eligibility criteria. Participants will receive either the drug, a placebo, or midazolam to compare the effects. The trial is designed to gather data on how well the drug is tolerated in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male individuals aged 18 to 50 years with a BMI between 20.0 and 29.9 kg/m².
Not a fit: Patients with any clinically relevant medical conditions or abnormal vital signs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety profile of BI 3031185, paving the way for its use in future treatments.
How similar studies have performed: Other studies evaluating the safety and tolerability of new drugs in healthy subjects have shown success, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Age of 18 to 50 years (inclusive) * 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 Exclusion Criteria: * Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator * Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 bpm * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Further exclusion criteria apply
Where this trial is running
Berlin
- Charité Research Organisation GmbH — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.