Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

Study Overview
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Brief Summary
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The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects

Official Title
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An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 113608 PIB
* Drug: BI 113608
* Drug: BI 113608
* Drug: BI 113608
* Drug: pantoprazole 40 mg STADA
* Drug: BI 113608


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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 BI 113608<br>powder in the bottle for oral solution, oral administration with 240 mL water | Drug: BI 113608 PIB<br>* powder for oral solution<br>|
| Experimental: 2 BI 113608<br>conventional tablet formulation | Drug: BI 113608<br>* conventional tablet formulation<br>|
| Experimental: 3 BI 113608<br>conventional tablet formulation, fed | Drug: BI 113608<br>* conventional tablet formulation<br>|
| Experimental: 4 BI 113608<br>conventional tablet after pantoprazole administration | Drug: pantoprazole 40 mg STADA<br>* film-coated tablet<br>Drug: BI 113608<br>* conventional tablet formulation<br>|
| Experimental: 5 BI 113608<br>conventional tablet formulation, fasted, 0:30 min before fat breakfast | Drug: BI 113608<br>* conventional tablet formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). | PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. | 
| Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax) | Maximum measured concentration of the analyte BI-113608 in plasma (Cmax). | PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) | Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity). | PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration. |