Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

Study Overview
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Brief Summary
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To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed

Official Title
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Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 425809 PfOS
* Drug: Placebo
* Drug: Placebo
* Drug: BI 425809 tablet
* Drug: BI 425809 PfOS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male subjects Age 18 to 45 years (incl.) Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.) Subject must be able to understand and comply with study requirements Exclusion criteria: Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator Repeated measurement of systolic blood pressure <90 or >140 mmHg, or diastolic blood pressure <50 or >90 mmHg, or pulse rate <50 or >90 Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged clinically relevant by the investigator Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 425809 single rising dose<br>BI 425809 powder for oral solution (PfOS) in single rising doses | Drug: BI 425809 PfOS<br>* BI 425809 PfOS<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: BI 425809 Crossover<br>Bioavailability of BI 425809 PfOS | Drug: Placebo<br>* Placebo<br>Drug: BI 425809 tablet<br>* BI 425809 tablet<br>Drug: BI 425809 PfOS<br>* BI 425809 PfOS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency [N(%)] of subjects with drug related adverse events (AEs) |  | up to 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 192 hours | 
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 192 hours |