Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBF 1120 capsules charge 2; Drug: BIBF 1120 capsules charge 1; Drug: BIBF 1120 drinking solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182193

1199.21

Details and patient eligibility

About

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)

Enrollment: 54 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

54 participants in 3 patient groups

BIBF 1120 capsules charge 1

Experimental group

Treatment:

Drug: BIBF 1120 capsules charge 1

BIBF 1120 capsules charge 2

Experimental group

Treatment:

Drug: BIBF 1120 capsules charge 2

BIBF 1120 drinking solution

Active Comparator group

Treatment:

Drug: BIBF 1120 drinking solution