Clinical trial NCT05515328: A Study in Healthy Men to Test How BI 685509 is Processed in the Body
Official title: Investigation of Metabolism and Pharmacokinetics and Absolute Bioavailability of BI 685509 (C-14) After Intravenous and Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study has two parts:

Part A: open-label, single-arm, single dose trial, Part B: non-randomised, open-label, fixed sequence crossover trial.
Primary purpose: TREATMENT

Brief summary: The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.

The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.


Eligibility criteria: 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 weight divided by height squared (kg/m2) (inclusive)
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Male subjects with women of child-bearing potential (WOCBP) partner who are vasectomised or willing to use male contraception (condom or sexual abstinence) from time point of study drug administration until 15 weeks thereafter

Exclusion Criteria:

* 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 of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 90 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, fainting spells, or blackouts
* further exclusion criteria apply

Primary outcomes:
measure: 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)
timeFrame: up to 14 days
measure: 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)
timeFrame: up to 14 days
measure: Part B: Absolute bioavailability of BI 685509 (%, obtained from a ratio of dose normalised values of AUCo-∞ after [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 administration)
timeFrame: up to 4 days
Secondary outcomes:
measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC₀-tz)
timeFrame: up to 14 days
measure: Part A: Maximum measured concentration of the analyte in plasma (Cₘₐₓ)
timeFrame: up to 14 days
measure: Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 to the last quantifiable time point (AUC₀-tz)
timeFrame: up to 4 days
measure: Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 extrapolated to infinity (AUC₀-∞)
timeFrame: up to 4 days
measure: Part B: Maximum measured concentration of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma (Cₘₐₓ)
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON
Study officials:
References: