Testing different doses of BI 3731579 in healthy volunteers

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

This study is testing different doses of a new drug called BI 3731579 in healthy volunteers to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Edegem)
• Trial ID: NCT06716190 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety, tolerability, and pharmacokinetics of BI 3731579 by administering multiple rising doses to healthy volunteers over a period of 15 days. Participants will receive either the active drug or a placebo, and their responses will be closely monitored through medical assessments and laboratory tests. The study is designed to gather important data on how the drug behaves in the body and its potential effects on health.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 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 provide valuable insights into the safety and dosing of BI 3731579 for future therapeutic applications.

How similar studies have performed: Other studies evaluating the safety and tolerability of new drugs in healthy volunteers have shown success, making this approach well-established.

Eligibility criteria

Inclusion criteria

1. Healthy volunteers 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), respiratory rate (RR) and temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 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 ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria

1. Any finding in the medical examination (including BP, PR, RR, temperature 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or resting pulse rate outside the range of 45 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

Edegem

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

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy