Healthy
Conditions
Brief summary
This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
Interventions
DRUG[14C]BI 1819479
\[14C\]BI 1819479
DRUGBI 1819479
BI 1819479
DRUGBI 1819479 (C-14)
BI 1819479 mixed with \[14C\]BI 1819479
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Both parts are conducted open-label.
Intervention model description
Part A is a single arm trial whereas Part B is conducted in a fixed-sequence.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male participants 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 without any clinically significant abnormalities 2. Age of 18 to 55 years (inclusive) 3. Body Mass Index (BMI) of 18.5 to 32.0 kg/m\^2 (inclusive) 4. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial 5. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only
Exclusion criteria
1. Any finding in the medical examination (including vital signs or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mm Hg, or heart rate outside the range of 45 to 90 bpm (beats per minute) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, assessed as clinically relevant by the investigator 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz) | Up to 37 days. |
| Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz) | Up to 37 days. |
| Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 31 days. |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Maximum measured concentration of [14C]BI 1819479-EQ in plasma (Cmax) | Up to 36 days. |
| Part A: Area under the concentration-time curve of [14C]BI 1819479-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz) | Up to 36 days. |
| Part B: Maximum measured concentration of [14C]BI 1819479 in plasma (Cmax) | Up to 31 days. |
| Part B: Maximum measured concentration of BI 1819479 in plasma (Cmax) | Up to 31 days. |
| Part B: Area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz) | Up to 31 days. |
| Part B: Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz) | Up to 31 days. |
Countries
United Kingdom
Outcome results
None listed