Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Study Overview
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Brief Summary
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Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1021958
* Drug: BI 1021958
* Drug: Placebo to BI 1021958


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1021958<br>Single rising dose (SRD) part | Drug: BI 1021958<br>* drinking solution / tablet<br>|
| Experimental: BI 1021958 (Food effect)<br>Food effect part (FE) | Drug: BI 1021958<br>* tablet<br>|
| Placebo Comparator: Placebo to BI 1021958<br>Matching placebo as drinking solution and tablets | Drug: Placebo to BI 1021958<br>* SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with clinically relevant findings in physical examination |  | up to 14 days postdose | 
| Number of participants with clinically relevant findings in vital signs |  | up to 14 days postdose | 
| Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results |  | up to 14 days postdose | 
| Number of participants with significant changes from baseline laboratory measurements |  | up to 14 days postdose | 
| Number of participants with adverse events |  | up to 14 days postdose | 
| Assessment of tolerability by investigator |  | up to 14 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of BI 1021958 in plasma) |  | up to 72h postdose | 
| area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) |  | up to 72h postdose | 
| AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point) |  | up to 72h postdose |