Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
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In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Official Title
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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 1015550
* Drug: BI 1015550
* Drug: BI 1015550
* Drug: BI 1015550
* Drug: BI 1015550
* Drug: Placebo
* Drug: BI 101550
* Drug: BI 1015550
* Drug: BI 1015550
* Drug: BI 1015550


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 1015550 low dose A<br>Powder for oral solution | Drug: BI 1015550<br>* Low dose powder for oral solution<br>|
| Experimental: BI 1015550 low dose B<br>Powder for oral solution | Drug: BI 1015550<br>* Low dose powder for oral solution<br>|
| Experimental: BI 1015550 low dose C<br>Powder for oral solution | Drug: BI 1015550<br>* Low dose powder for oral solution<br>|
| Experimental: BI 1015550 low dose D<br>Powder for oral solution | Drug: BI 1015550<br>* Low dose powder for oral solution<br>|
| Experimental: BI 1015550 medium dose A<br>Powder for oral solution | Drug: BI 1015550<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 1015550 medium dose B<br>Powder for oral solution | Drug: BI 1015550<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 1015550 medium dose C<br>Powder for oral solution | Drug: BI 1015550<br>* Medium dose powder for oral solution<br>|
| Experimental: BI 1015550 high dose A<br>Powder for oral solution | Drug: BI 1015550<br>* High dose powder for oral solution<br>|
| Experimental: BI 1015550 high dose B<br>Powder for oral solution | Drug: BI 101550<br>* High dose powder for oral solution<br>|
| Placebo Comparator: Placebo<br>Solution for oral administration | Drug: Placebo<br>* Solution for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number (%) of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events. | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. | 
| Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests | Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis). | Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). | 
| Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs | Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test). | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). | 
| Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs | Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs. | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). | 
| Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability | Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator. | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. | 
| Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations | Percentage of subjects with clinically relevant abnormalities in physical examinations. | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of BI 1015550 | Maximum measured concentration of the analyte in plasma. | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| AUC0-infinity of BI 1015550 | Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |