Clinical trial NCT06520553: A Study in Healthy Men to Test How BI 1569912 is Processed in the Body
Official title: A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are:

* To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
* To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)


Eligibility criteria: Inclusion Criteria :

Subjects will only be included in the trial if they meet the following criteria:

1. 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
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m 2 (inclusive)
4. Signed and dated written informed consent in accordance with 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:

1. Any finding in the medical examination (including BP, PR 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 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Further exclusion criteria apply

Primary outcomes:
measure: Mass balance recovery for [ 14 C]- radioactivity in urine after oral administration of BI 1569912 (C-14): fe urine,0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
timeFrame: up to Day 14.
measure: Mass balance recovery for [ 14 C]- radioactivity in faeces after administration of BI 1569912 (C-14): fe faeces,0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
timeFrame: up to Day 14.
measure: Mass balance recovery for [14C]- radioactivity in urine and faeces after oral administration of BI 1569912 (C-14): Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
timeFrame: up to Day 14.
measure: AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
timeFrame: up to Day 13.
measure: AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of [ 13 C] BI 1569912 after a single intravenous infusion of BI 1569912 (C-13)
timeFrame: up to Day 6.
Secondary outcomes:
measure: Cmax (maximum measured concentration in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
timeFrame: up to Day 13.
measure: AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
timeFrame: up to Day 13.
measure: Cmax (maximum measured concentration in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)
timeFrame: up to Day 13.
measure: AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)
timeFrame: up to Day 13.
measure: Cmax of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C- 13)
timeFrame: up to Day 6.
measure: AUC0-tz of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C-13)
timeFrame: up to Day 6.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON-Groningen-62040
Study officials:
References: