Healthy
Conditions
Brief summary
To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)
Interventions
DRUGBIBF 1120 capsules charge 1
DRUGBIBF 1120 capsules charge 2
DRUGBIBF 1120 drinking solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects as determined by results of screening 2. Signed written informed consent in accordance with GCP and local legislation 3. Age ≥21 and ≤55 years 4. Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Exclusion criteria
1. Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance 2. History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders 3. History of relevant orthostatic hypotension, fainting spells and blackouts 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. Chronic or relevant acute infections 6. History of allergy/hypersensitivity (including drug allergy or its excipients) which is deemed relevant to the trial as judged by the investigator 7. History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri 8. Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration 9. Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial 10. Participation in another trial with an investigational drug within 2 months prior to administration or during trial 11. Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days 12. Alcohol abuse (\> 60 g/day) 13. Drug abuse 14. Blood donation (more than 150 mL within 4 weeks prior to administration or during the trial) 15. Excessive physical activities within 5 days prior to administration or during the trial 16. Any laboratory value outside the reference range that is of clinical relevance 17. Female gender 18. Male subjects refuse to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞) | 1 h pre dose and up to 48 h after drug administration |
| Individual maximum observed concentrations of the analyte in plasma (Cmax) | 1 h pre dose and up to 48 h after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal rate constant in plasma (λz) | 1 h pre dose and up to 48 h after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | 1 h pre dose and up to 48 h after drug administration |
| Mean residence time of the analyte in the body after oral administration (MRTpo) | 1 h pre dose and up to 48 h after drug administration |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | 1 h pre dose and up to 48 h after drug administration |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | 1 h pre dose and up to 48 h after drug administration |
| Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24) | 1 h pre dose and up to 24 h after drug administration |
| Change in routine laboratory values | pre-dose, up to 48 hours after drug administration |
| Change in ECG | pre-dose, 4 hours after drug administration, day 32 |
| Occurrence of adverse events | up to 32 days after drug administration |
| Assessment of tolerability by investigator on a 4 point scale | 48 hours after drug administration |
| Change in vital signs (blood pressure, pulse rate) | Baseline, up to 24 hours after drug administration |
| time from dosing to the maximum concentration of the analyte in plasma (tmax) | 1 h pre dose and up to 48 h after drug administration |
Outcome results
None listed