Healthy
Conditions
Brief summary
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
Interventions
DRUGBIBF 1120
150 mg of BIBF 1120 ES soft gelatine capsules
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects as determined by results of screening * Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation * Age ≥21 and ≤55 years * Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * History of orthostatic hypotension, fainting spells and blackouts * Diseases 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 * 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 * Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration * Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within 2 months prior to administration or during trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation within 1 month prior to administration or during the trial * Excessive physical activities within 5 days prior to administration or during the trial * Any laboratory value outside the clinically accepted reference range * Female gender * Male subjects must agree 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 |
|---|---|
| AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Cmax (maximum observed concentration in plasma) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| tmax (time from dosing to reach Cmax) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| CL/F (apparent clearance in plasma following extravascular administration) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Vz/F (apparent volume of distribution during the terminal phase following extravascular administration) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Incidence and intensity of adverse events | up to 14 days |
| t1/2 (terminal half-life in plasma) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
| Changes from baseline in laboratory tests | up to 14 days |
| Assessment of global tolerability on a 4-point scale | Day 3 of each treatment period |
| Changes from baseline in 12-lead electrocardiogram | up to 14 days |
| Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate) | up to 14 days |
| MRTpo (mean residence time in the body) | Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug |
Outcome results
None listed