The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following administration of single rising doses and administration of multiple rising doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
BI 3804379
Placebo matching BI 3804379
SGS Life Science Services - Clinical Research
Edegem, Belgium
RECRUITINGPart A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Time frame: Up to Day 84 for Part A and up to Day 235 for Part B and Part C.
Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity)
Time frame: Up to Day 84.
Part A: Cmax (maximum measured concentration of the analyte in serum)
Time frame: Up to Day 84.
Part B and Part C: AUCτ,ss (area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ)
Time frame: Up to Day 235.
Part B and Part C: Cmax,ss (maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ)
Time frame: Up to Day 235.
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