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

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
BIBB 515 BS	BIBB 515 BS	-
BIBB 515 BS after a standard breakfast	Standard breakfast (40 g fat)	-
BIBB 515 BS after a standard breakfast	BIBB 515 BS	-

Primary Outcome Measures

Name	Time	Method
Total mean residence time of the analyte in the body (MRTtot)	Up to 48 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)	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
Apparent volume of distribution of the analyte during the terminal phase (Vz/f)	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
Time to reach maximum concentration of the analyte in plasma (tmax)	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
Maximum concentration of the analyte in plasma (Cmax)	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

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility