It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
1334.2.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related Adverse events (AEs)
Time frame: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Time frame: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
Cmax (Maximum Measured Concentration of the Analyte Inplasma)
Cmax (maximum measured concentration of the analyte inplasma). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Time frame: 0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Time frame: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
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BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
Placebo
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study.
Time frame: 312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration