Clinical Trials in Germany / NCT06745297
Recruiting
Phase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
NCT06745297 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Healthy
Investigational drug(s) / intervention(s)
BI 3776528Placebo matching BI 3776528short-acting benzodiazepine
BI 3776528: BI 3776528
Placebo matching BI 3776528: Placebo matching BI 3776528
short-acting benzodiazepine: short-acting benzodiazepine
Study summary
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
Eligibility
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.
Primary outcome measure(s)
- Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator — up to 62 days
- Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) — up to 27 days
- Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma) — up to 27 days
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | Germany | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06745297 on ClinicalTrials.gov ↗ ← All trials in Germany