The objective of this trial was to investigate the safety, tolerability, pharmacokinetics, and relative bioavailability of BI 207127 NA as powder in the bottle (PIB) and solid oral dosage form (tablets) without and with food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Number of patients with abnormal findings in physical examination
Time frame: Baseline, within 14 days after last trial procedure
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR)
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with abnormal changes in clinical laboratory tests
Time frame: Baseline, up to 14 days after last trial procedure
Number of patients with adverse events
Time frame: up to 44 days
Assessment of tolerability on a 4-point scale by investigator
Time frame: within 14 days after last trial procedure
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 72 hours after drug administration
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 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to the last observed plasma concentration)
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Time frame: up to 72 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
MRToral (mean residence time of the analyte in the body after oral administration)
Time frame: up to 72 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after oral administration)
Time frame: up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)
Time frame: up to 72 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 48 hours after drug administration