COMBINATION_PRODUCT
BI 456906 formulation A
BI 456906 formulation A
Status
Completed
Phase
Phase 1
Enrollment
16
Locations
1
Results
Not posted
Publications
0
Study summary
The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).
Interventions
COMBINATION_PRODUCT
BI 456906 formulation A
DRUG
BI 456906 formulation B2
Timeline
First posted
Jul 18, 2025
Study start
Jul 28, 2025
Primary completion
Oct 7, 2025
Study completion
Oct 28, 2025
Results posted
Not reported
Registry updated
Mar 13, 2026
Outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame · Up to 22 days.
Cmax (maximum measured concentration of the analyte in plasma)
Time frame · Up to 22 days.
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame · Up to 22 days.
Eligibility
Inclusion Criteria Trial participants will only be included in the trial if they meet the following criteria: 1. Healthy male or female 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 2. Age of 18 to 55 years (inclusive) 3. Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply. Exclusion Criteria : Participants will not be allowed to participate, if any of the following general criteria apply: 1. Any finding in the medical examination (BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 50 to 90 mmHg, or PR 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 and, in particular: * Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20% * Aspartate aminotransferase (AST) above Upper limit of normal (ULN) + 20% * Gamma Glutamil Transferase (GGT) above Upper limit of normal (ULN) + 20% * Lipase or amylase above Upper limit of normal (ULN) + 20% * Bilirubin above 1.2x Upper limit of normal (ULN) (except for cases of Gilbert's Syndrome) * Estimated Glomerular Filtration Rate Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73 m² 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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