Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667

Study Overview
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Brief Summary
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The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: BI 639667


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male subjects age of 18 to 50 years body mass index (BMI) of 18.5 to 29.9 kg/m2 Exclusion criteria: Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mmHg, or pulse rate outside the range of 50 to 90 mmHg at screening 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 (except appendectomy and simple hernia repair) 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: 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 639667<br>single rising doses given as oral solution | Drug: BI 639667<br>* oral solution BI 639667, single rising doses<br>|
| Placebo Comparator: Placebo<br>placebo solution | Drug: Placebo<br>* placebo solution<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 |  | up to 19 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | up to 120 hours postdose | 
| Cmax (maximum measured concentration of the analyte in plasma) |  | up to 120 hours postdose |