Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

Study Overview
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Brief Summary
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The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Official Title
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Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 113608 PIB bid
* Drug: Placebo to BI 113608 PIB bid
* Drug: Placebo to BI 113608 PIB bid
* Drug: Placebo to BI 113608 PIB qd
* Drug: Placebo to BI 113608 PIB bid
* Drug: BI 113608 PIB bid
* Drug: BI 113608 PIB bid
* Drug: BI 113608 PIB qd


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

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 113608 high dose bid<br>powder in the bottle for oral solution, oral administration with 240 ml water | Drug: Placebo to BI 113608 PIB bid<br>* powder for oral solution<br>Drug: BI 113608 PIB bid<br>* powder for oral solution<br>|
| Experimental: BI 113608 low dose bid<br>powder in the bottle for oral solution, oral administration with 240 ml water | Drug: Placebo to BI 113608 PIB bid<br>* powder for oral solution<br>Drug: BI 113608 PIB bid<br>* powder for oral solution<br>|
| Experimental: BI 113608 medium dose bid<br>powder in the bottle for oral solution, oral administration with 240 ml water | Drug: BI 113608 PIB bid<br>* powder for oral solution<br>Drug: Placebo to BI 113608 PIB bid<br>* powder for oral solution<br>|
| Experimental: BI 113608 high dose qd<br>powder in the bottle for oral solution, oral administration with 240 ml water | Drug: Placebo to BI 113608 PIB qd<br>* powder for oral solution<br>Drug: BI 113608 PIB qd<br>* powder for oral solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Drug-related Adverse Events | Percentage of participants with drug-related adverse events | From administration of study drug until end-of-study, up to 17 days | 
| Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings | Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG) | From administration of study drug until end-of-study, up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss | Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss). | 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment. | 
| Tmax,ss | Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss). | 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment. | 
| AUCtau,ss | Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss). | 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment. | 
| t1/2,ss | Terminal half-life of the analyte in plasma at steady state (t1/2,ss). | 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose. | 
| RA,Cmax | Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax). | -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose. | 
| RA,AUC | Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC). | -2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose. |