A Study in Healthy Men to Test How BI 685509 is Processed in the Body

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Metabolism and Pharmacokinetics and Absolute Bioavailability of BI 685509 (C-14) After Intravenous and Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [¹⁴C] BI 685509 formulation 1
* Drug: [¹⁴C] BI 685509 formulation 2
* Drug: BI 685509 formulation 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Arm 1<br> | Drug: [¹⁴C] BI 685509 formulation 1<br>* [¹⁴C] BI 685509 formulation 1<br>|
| Experimental: Part B: Arm 1 - Reference<br> | Drug: [¹⁴C] BI 685509 formulation 2<br>* [¹⁴C] BI 685509 formulation 2<br>|
| Experimental: Part B: Arm 2 - Treatment<br> | Drug: BI 685509 formulation 3<br>* BI 685509 formulation 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | up to 14 days | 
| 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) |  | up to 14 days | 
| 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) | AUCo-∞: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | up to 14 days | 
| Part A: Maximum measured concentration of the analyte in plasma (Cₘₐₓ) |  | up to 14 days | 
| 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) |  | up to 4 days | 
| 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-∞) |  | up to 4 days | 
| Part B: Maximum measured concentration of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma (Cₘₐₓ) |  | up to 4 days |