Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

Study Overview
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Brief Summary
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To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Official Title
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Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: BI 1015550
* Drug: BI 1015550
* Drug: BI1015550
* Drug: BI 1015550


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male subjects Exclusion criteria: Any relevant deviation from healthy conditions Subjects unable to understand or to comply with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo to BI 1015550<br>placebo | Drug: Placebo<br>* Placebo to BI 1015550<br>|
| Experimental: BI 1015550 low dose 1<br>powder for oral solution | Drug: BI 1015550<br>* low dose 1 powder for oral solution<br>|
| Experimental: BI 1015550 low dose 2<br>powder for oral solution | Drug: BI1015550<br>* low dose 2 powder for oral solution<br>|
| Experimental: BI 1015550 medium dose 1<br>powder for oral solution | Drug: BI 1015550<br>* medium dose 1 powder for oral solution<br>|
| Experimental: BI 1015550 medium dose 2<br>powder for oral solution | Drug: BI 1015550<br>* medium dose 2 powder for oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Drug-related Adverse Events | Percentage of subjects with drug related Adverse events, as assessed by the investigator. | From first drug administration until last drug administration, upto 18 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum measured concentration of BI 1015550 in plasma. | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. | 
| AUCt,1 | Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration | 
| AUC0-infinity | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. | 
| Cmax,ss | Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t. | 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h. | 
| AUCt,ss | Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t. | 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h. |