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A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

RecruitingPhase 1Ages 18 Years - 50 YearsMaleBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mยฒ (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.
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What it tests

  • BI 3776528
  • Placebo matching BI 3776528
  • short-acting benzodiazepine
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Where

1 site
Charitรฉ Research Organisation GmbH
Berlin, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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