Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects

Study Overview
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Brief Summary
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To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules

Official Title
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Single-dose Pharmacokinetics of 2.5 mg BIBB 515 BS and Effect of Food After Oral Administration of Capsules to Healthy Subjects (Randomized, 2-way-cross-over, Open Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBB 515 BS
* Other: Standard breakfast (40 g fat)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male caucasian subjects as determined by results of screening Written informed consent in accordance with good clinical practice (GCP) and local legislation Age ≥ 18 and ≤ 50 years Broca ≥ - 20 % and ≤ + 20 % Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders History of orthostatic hypotension, fainting spells or blackouts Chronic or relevant acute infections History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Intake of drugs with a long half-life (> 24 hours) (≤ 1 month prior to administration or during the trial) Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial) Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on study days Alcohol abuse (> 60 g/day) Drug abuse Blood donation > 100 ml (≤ 4 weeks prior to administration or during the trial) Excessive physical activities (≤ 10 days prior to administration or during the trial) Any laboratory value outside the reference range of clinical relevance

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 |
| --- | --- |
| Experimental: BIBB 515 BS after a standard breakfast<br> | Drug: BIBB 515 BS<br> <br> Other: Standard breakfast (40 g fat)<br> <br> |
| Active Comparator: BIBB 515 BS<br> | Drug: BIBB 515 BS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration of the analyte in plasma (Cmax) |  | Up to 48 hours after drug administration | 
| Time to reach maximum concentration of the analyte in plasma (tmax) |  | Up to 48 hours after drug administration | 
| Apparent terminal elimination half-life of the analyte in plasma (t1/2) |  | Up to 48 hours after drug administration | 
| Area under the concentration-time curve of the analyte in plasma at different time points (AUC) |  | Up to 48 hours after drug administration | 
| Total mean residence time of the analyte in the body (MRTtot) |  | Up to 48 hours after drug administration | 
| Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/f) |  | Up to 48 hours after drug administration | 
| Apparent volume of distribution of the analyte during the terminal phase (Vz/f) |  | Up to 48 hours after drug administration | 
| Terminal rate constant of the analyte in plasma (λz) |  | Up to 48 hours after drug administration | 
| Number of patients with adverse events |  | Up to 48 hours after last drug administration | 
| Global clinical assessment by the investigator |  | Day 3 after last drug administration |