Clinical trial NCT05879991: A Study in Healthy Men to Test How BI 1810631 is Taken up and Processed by the Body
Official title: A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 1810631 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability of BI 1810631 Administered as Film-coated Tablet Together With an Intravenous Microtracer Dose of BI 1810631 (C-14) (Part B) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Part A - the primary objective is to assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.

Part A - the secondary objective is to assess concentrations of BI 1810631 and \[14C\]-radioactivity in plasma.

Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer.


Eligibility criteria: Inclusion 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 18.0 to 30.0 kg/m2 (inclusive)
4. 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:

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 145 millimetre 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)
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
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 exclusion criteria apply

Primary outcomes:
measure: Part A - Mass balance and total recovery of [14C]-radioactivity in urine: feurine, 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 43 days
measure: Part A - Mass balance and total recovery of [14C]-radioactivity in faeces: fefaeces, 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 43 days
measure: Part B - For [14C]BI 1810631 after intravenous administration and for BI 1810631 after oral administration in plasma: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)
timeFrame: up to 8 days
Secondary outcomes:
measure: Part A - For BI 1810631 and for [14C]-radioactivity in plasma: Cmax (maximum measured concentration of the analyte)
timeFrame: up to 15 days
measure: Part A - For BI 1810631 and for [14C]-radioactivity in plasma: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
timeFrame: up to 15 days
measure: Part B - For [14C]BI 1810631 after intravenous administration and for BI 1810631 after oral administration in plasma: Cmax (maximum measured concentration of the analyte)
timeFrame: up to 8 days
measure: Part B - For [14C]BI 1810631 after intravenous administration and for BI 1810631 after oral administration in plasma: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
timeFrame: up to 8 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON
Study officials:
References: