Bioavailability of Oral BIRB 796 BS Tablets With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers

Study Overview
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Brief Summary
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Study to assess the effect of gastric pH on the pharmacokinetics of BIRB 796 BS. Safety and tolerability were also assessed.

Official Title
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An Open Label, Randomised, Crossover Study of the Bioavailability of Oral BIRB 796 BS Tablets (30 mg Single Dose) With and Without Administration of Oral Pantoprazole in Healthy Male Volunteers to Assess the Effect of Gastric pH on Absorption of BIRB 796 BS.

Conditions
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Healthy

Intervention / Treatment
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* Device: BIBR 796 BS
* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects as determined by results of screening Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation Age >=18 and <=55 years Laboratory examinations within a clinically defined reference range Helicobacter pylori negative Able to tolerate pH probe application Body mass index (BMI) >=18.5 and <=29.9 kg/m2 Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders Surgery of gastrointestinal tract (excluding appendectomy) History of orthostatic hypotension, fainting spells or blackouts Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator including study drugs History of vasculitis (past history of fever, malaise, myalgias, rash, etc.) Intake of drugs with a long half-life (> 24 hours) within 1 month or 10 half lives of that drug, whichever is longer, prior to administration of study drugs or during the trial Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial Use of grapefruit or grapefruit juice, alcohol, green tea, methylxanthine-containing products or tobacco within 5 days of study drug administration Participation in another trial with an investigational drug within 1 month prior to administration or during the trial Smoker Alcohol abuse (> 60 g/day) Drug abuse Blood or plasma donation (>400 ml) within 1 month prior to administration or during trial Excessive physical activities within 5 days prior to administration or during the trial Following specific laboratory findings: aspartate aminotransferase, alanine transaminase, Gamma-glutamyl-transferase above the reference range Inability to comply with dietary regimen of study centre Inability to comply with investigator's instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: BIBR 796 BS + pantoprazole<br> | Device: BIBR 796 BS<br>* single dose<br>Drug: Pantoprazole<br>* 5 days<br>|
| Active Comparator: BIBR 796 BS without pantoprazole<br> | Device: BIBR 796 BS<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve from time 0 mathematically extrapolated to time infinity (AUC0-inf.) |  | up to 36 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | up to 36 hours after drug administration | 
| Area under the plasma concentration versus time curve over a given time interval (AUC0-t) |  | up to 36 hours after drug administration | 
| Time to the maximum plasma concentration (tmax) |  | up to 36 hours after drug administration | 
| Apparent oral clearance (CL/F) |  | up to 36 hours after drug administration | 
| Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F) |  | up to 36 hours after drug administration | 
| Elimination half-life (t1/2) |  | up to 36 hours after drug administration | 
| Mean residence time (MRT) |  | up to 36 hours after drug administration | 
| Gastric pH measurements |  | up to 12 hours after drug administration | 
| Number of patients with adverse events |  | up to 34 days | 
| Assessment of tolerability | based on the ability of the subjects to take the medicine as well as occurence of adverse events and abnormal laboratory investigations | on the last 1 day of second treatment |