Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food

Boehringer Ingelheim73 enrolled

Overview

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level). Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison) Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase). MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: MALEMin age: 19 YearsMax age: 54 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy 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 * Broca \> - 20% and \< + 20% Exclusion Criteria: * Any findings 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 (including thyroid) disorder * Surgery of the gastro-intestinal tract (except appendectomy) * Disease of the central nervous system (such as epilepsy) or psychiatric 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 * 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 result of the trial (\<= 10 days prior to administration or during the trial) * Participation in another trial with an investigational drug (\<= 2 month prior to administration or during the trial) * Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day) * Inability to refrain from smoking during the period of the study * Known alcohol (\>60 g/day) or drug abuse * Blood donation (\<=1 month prior to administration) * Excessive physical activities (\<5 days prior to administration) * Any laboratory value outside the normal range of clinical relevance * History of hemorrhagic diatheses * History of gastro-intestinal ulcer, perforation or bleeding * History of bronchial asthma