The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
172
Charité Research Organisation GmbH
Berlin, Germany
RECRUITINGPart 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to 62 days
Part 1b: AUC0-tz of BI 3776528 in plasma (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 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
Time frame: up to 27 days
Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 27 days
Part 1a: Cmax of BI 3776528 in plasma
Time frame: up to 27 days
Part 1b: AUC0-∞ of BI 3776528 in plasma
Time frame: up to 27 days
Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 days
Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 days
Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 27 days
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