To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

Study Overview
=================
Brief Summary
-----------------
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

Official Title
-----------------
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)

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

Intervention / Treatment
-----------------
* Drug: BI 1026706 Placebo
* Drug: BI 1026706


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 BI 1026706 single rising dose part<br>single rising doses of BI 1026706 | Drug: BI 1026706 Placebo<br>* Placebo to BI 1026706<br>Drug: BI 1026706<br>* different dose formulations<br>|
| Experimental: 2 BI 1026706 bioavailability part<br>bioavailability part of BI 1026706 | Drug: BI 1026706<br>* different dose formulations<br>|

What is the study measuring?
-----------------
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 first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum measured concentration of the analyte in plasma (Cmax). The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1. | -2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| Tmax (Time From Dosing to Maximum Measured Concentration) | Time from dosing to maximum measured concentration (tmax). | -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| AUC0-inf | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). | -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| AUC0- tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0- tz). | -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| t1/2 (Terminal Half-life of the Analyte in Plasma) | Terminal half-life of the analyte in plasma (t1/2). | -2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing | 
| f t1-t2 (SRD-Part) | Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2). | 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours |