Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306

Study Overview
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Brief Summary
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The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. for 14 Days in Young and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 409306 BS
* Drug: BI 409306 BS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy male/female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

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

Sexes Eligible for Study
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All

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: BI 409306 BS medium dose<br>Film-coated tablet | Drug: BI 409306 BS<br>* Medium dose film-coated tablet<br>|
| Experimental: BI 409306 BS high dose<br>Film-coated tablet | Drug: BI 409306 BS<br>* High dose film-coated tablet<br>|
| Placebo Comparator: Placebo<br>Film-coated tablet | Drug: Placebo<br>* Film-coated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 11 weeks | 
| Number of participants with clinically relevant findings in physical examination |  | Up to 11 weeks | 
| Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results |  | Up to 11 weeks | 
| Number of participants with significant changes from baseline laboratory measurements |  | Up to 11 weeks | 
| Assessment of tolerability by investigator (global assessment) |  | Up to 11 weeks | 
| Suicidality assessment |  | Up to 11 weeks | 
| Color discrimination test |  | Up to 11 weeks | 
| Visual acuity test |  | Up to 11 weeks | 
| Number of participants with clinically relevant findings in Vital signs (blood pressure, pulse rate, orthostasis test) |  | Up to 34 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum measured concentration of the analyte in plasma) |  | Up to 11 weeks | 
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) |  | Up to 11 weeks | 
| AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours) |  | Up to 11 weeks | 
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) |  | Up to 17 days | 
| tmax,ss (time from last dosing to Cmax,ss) |  | Up to 17 days | 
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) |  | Up to 17 days |