Testing how well different doses of BI 3776528 are tolerated in healthy men

A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants

This study is testing how well different doses of a new medication are tolerated by healthy men aged 18 to 50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Male
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT06745297 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety, tolerability, and pharmacokinetics of varying doses of BI 3776528 in healthy male participants. It involves administering both the drug and a placebo to assess how well the body tolerates the medication. The study is designed for healthy males aged 18 to 50 with specific body mass index (BMI) criteria. Participants will undergo thorough medical examinations to ensure they meet the inclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are healthy males aged 18 to 50 with a BMI between 18.5 and 29.9 kg/m².

Not a fit: Patients with significant 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 3776528, potentially paving the way for its use in treating various conditions.

How similar studies have performed: Other studies have shown success in evaluating the safety and tolerability of new drugs in healthy populations, 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 and clinical laboratory.
2. Age of 18 to 50 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 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 (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
4. 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

Conditions Healthy