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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
BI 3009947 (Formulation A)
BI 3009947 (Formulation B)
Placebo matching BI 3009947 (Formulation A)
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
RECRUITINGSRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
Time frame: up to Day 14
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 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)
Time frame: up to Day 3
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Time frame: up to Day 3
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Time frame: up to Day 3
SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Time frame: up to Day 3
SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Time frame: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to Day 3
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