Clinical trial NCT06572111: A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body
Official title: A Phase I, Open-label Trial to Investigate the Metabolism, Pharmacokinetics (Following a Mass Balance Design; Part A) and Absolute Bioavailability of BI 1839100 (C-14) After Oral and Intravenous Administration (Part B) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Part A: open-label, single arm, single-dose Part B: non-randomized, open-label, single-arm, single period, fixed sequence, crossover
Primary purpose: TREATMENT

Brief summary: This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.


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 electronic cardiogram (ECG), and clinical laboratory tests.
2. Age of 18 to 59 years (inclusive at screening)
3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive at screening)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or ECG that deviates from normal and is assessed as clinically significant by the investigator
2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm (subjects with PR values between 45 and 50 bpm may only be enrolled in case they have normal thyroid function (thyroid-stimulating hormone (TSH) and free thyroxine (FT4) at baseline-screening, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical significance
4. Any evidence of a concomitant disease assessed as clinically significant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically significant by the investigator
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the Pharmacokinetics (PKs) 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 assessed as clinically relevant by the investigator
8. History of significant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: Mass balance and total recovery of [C-14]-radioactivity in urine and feces.
timeFrame: From drug administration up to Day 21.
measure: Area under the concentration-time curve of Carbon-14-labeled BI 1839100 after intravenous administration and BI 1839100 after oral administration, extrapolated to infinity (AUC0-∞).
timeFrame: From drug administration up to Day 21.
Secondary outcomes:
measure: Maximum measured concentration of BI 1839100 and Carbon-14-labeled BI 1839100 in plasma (Cmax).
timeFrame: Two hours before drug administration up to Day 21.
measure: Area under the concentration-time curve of BI 1839100 and Carbon-14-labeled BI 1839100 from 0 to the last quantifiable time point (AUC0-tz).
timeFrame: Two hours before drug administration up to Day 21.
measure: Area under the concentration-time curve of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration, from 0 to the last quantifiable time point (AUC0-tz).
timeFrame: Two hours before drug administration up to 72 hours (Day 4).
measure: Maximum measured concentration of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration (Cmax).
timeFrame: Two hours before drug administration up to 72 hours (Day 4).
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON-Groningen-62040
Study officials:
References: