Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Pharmacokinetics/Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules With and Without Food to Healthy Male Volunteers in an Open, Randomised, Intra-individual Crossover Comparison Design

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIBF 1120


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: fasted administration of BIBF 1120<br>150 mg of BIBF 1120 ES soft gelatine capsules in fasting state | Drug: BIBF 1120<br>* 150 mg of BIBF 1120 ES soft gelatine capsules<br>|
| Experimental: fed administration of BIBF 1120<br>three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal | Drug: BIBF 1120<br>* 150 mg of BIBF 1120 ES soft gelatine capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate) |  | up to 14 days | 
| 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 |