A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Differ… (NCT07250048) | Clinical Trial Compass
TerminatedPhase 1
A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood
Stopped: Sponsor decision
Germany40 participantsStarted 2025-11-21
Plain-language summary
Single-rising dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses.
Bioavailability (BA) part:
The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Healthy male trial participant 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
✓. Age of 18 to 45 years (inclusive)
✓. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
✓. Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion criteria
✕. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
✕. Repeated measurement 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 bpm
✕. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
What they're measuring
1
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Timeframe: up to Day 14
2
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Timeframe: up to Day 3
3
BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Timeframe: up to Day 3
4
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Timeframe: up to Day 3
5
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
. Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)