Healthy
Conditions
Brief summary
The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.
Interventions
DRUGBI 690517 (C-14)
BI 690517 (C-14)
DRUGBI 690517
BI 690517
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests. * Age of 18 to 55 years (inclusive). * Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive). * Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Exclusion criteria
Subjects will not be allowed to participate, if any of the following general criteria apply: * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. * Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm). * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. * Any evidence of a concomitant disease assessed as clinically relevant by the investigator. * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair). * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders. * History of relevant orthostatic hypotension (including but not limited to a reduction in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg within 3 minutes of standing during screening measurement associated with clinical symptoms), fainting spells, or blackouts. Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞) | Up to 3 days. |
| Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞) | Up to 3 days. |
| Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz ) | Up to 22 days. |
| Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz) | Up to 22 days. |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) | Up to 8 days. |
| Part A: Maximum measured concentration of the analyte in plasma (Cmax) | Up to 8 days. |
| Part B: Maximum measured concentration of the analyte in plasma (Cmax) | Up to 3 days. |
| Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) | Up to 3 days. |
Countries
Netherlands
Outcome results
None listed