Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
1314.9.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea
Number (%) of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.
Time frame: Up to 21 days (4 days for SRD period and 17 days for MRD period)
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
maximum measured concentration of the analyte in plasma after a single dose of BI 113608.
Time frame: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)
Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.
Time frame: 0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)
Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
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Placebo (Single dosing)
High dose (Single dosing)
Medium dose (Single dosing)
Low dose (Single dosing)
High dose (Multiple dosing)
t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)
Terminal half-life of the analyte in plasma after a single dose of BI 113608.
Time frame: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration
Cmax,ss
Maximum measured concentration of the analyte in plasma at steady state
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
Tmax,ss
Time from last dosing to maximum concentration of the analyte in plasma at steady state
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
AUCtau,ss
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
t1/2,ss
Terminal half-life of the analyte in plasma at steady state
Time frame: 23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h
RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)
Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose
Time frame: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD
RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)
Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose
Time frame: 0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD