Testing the safety and tolerability of BI 3731579 in healthy men

A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects

This study is testing the safety and how well the body can handle a new drug called BI 3731579 in healthy men aged 18 to 45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Male
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Biberach)
• Trial ID: NCT06429137 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety, tolerability, and pharmacokinetics of BI 3731579 in healthy male participants aged 18 to 45. The study will involve administering different doses of the drug alongside a matching placebo to assess how well the body tolerates the medication. Participants will undergo thorough medical evaluations, including physical exams and laboratory tests, to ensure they meet the eligibility criteria. The findings from this trial will help inform future studies and potential therapeutic uses of BI 3731579.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male individuals aged 18 to 45 with a BMI between 18.5 and 29.9.

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 lead to a better understanding of the safety profile of BI 3731579, paving the way for its use in treating various conditions.

How similar studies have performed: Other studies have successfully evaluated the safety and tolerability of new medications in healthy volunteers, making this approach well-established.

Eligibility criteria

Inclusion criteria

1. 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
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Where this trial is running

Biberach

• Humanpharmakologisches Zentrum Biberach — Biberach, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy