To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

Study Overview
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Brief Summary
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To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Official Title
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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 416970 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, Investigation of Relative Bioavailability of BI 416970 (Open-label, Randomised, Three-way Cross-over) and Assessment of Safety and Exposure of BI 416970 in CYP2C9 Genotyped Volunteers (Open-label, Single-dose)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo to BI 416970
* Drug: BI 416970


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory Age 18 to 50 years (incl.) Body Mass Index 18.5 to 29.9 kg/m2 (incl.) Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Known genotype of CYP2C9 isoenzyme Exclusion criteria: Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range of 50 to 90 bpm Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged as 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 trial medication Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 416970 single rising dose part<br>single rising dose given as tablet | Drug: Placebo to BI 416970<br>* single rising doses<br>Drug: BI 416970<br>* single rising doses<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 | AEs were recorded throughout the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Cmax (maximum measured concentration of the analyte in plasma) | 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration | 
| AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) | AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration |