Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.

Official Title
-----------------
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Matching placebo
* Drug: BI 1181181 healthy elderly
* Drug: BI 1181181 Healthy young


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers. BMI of 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. Exclusion criteria: Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator 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) Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 1181181 healthy young<br>Medium doses as tablets q.d. for 10 days | Drug: BI 1181181 Healthy young<br>* Tablet<br>|
| Experimental: BI 1181181 healthy elderly<br>Medium doses as tablets q.d. for 10 days | Drug: BI 1181181 healthy elderly<br>* Tablet<br>|
| Placebo Comparator: Matching placebo in healthy young<br>Matching placebo for 10 days | Drug: Matching placebo<br>* Tablet<br>|
| Placebo Comparator: Matching placebo in healthy elderly<br>Matching placebo for 10 days | Drug: Matching placebo<br>* Tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency [N (%)] of subjects with drug-related adverse events |  | days 1 to 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose |  | 0 to 336 hours | 
| Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose |  | 0 to 336 hours | 
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) |  | 0 to 336 hours | 
| Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose |  | 0 to 336 hours | 
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose |  | 0 to 336 hours | 
| AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose |  | 0 to 336 hours |