Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BIBF 1120 ES

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182154

1199.20

Details and patient eligibility

About

To assess the metabolic profile,

to obtain the mass balance after oral administration,

to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and faeces,

to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if feasible,

to determine the protein binding of [14C]-radioactivity,

to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a single oral administration of [14C]-BIBF 1120 in healthy volunteers

Enrollment: 8 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 any major surgery within the last four weeks before participation in this study or any bone fracture within the last two months
4. History of orthostatic hypotension, fainting spells and blackouts
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
8. History of any bleeding disorder including prolonged or habitual bleeding, other haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
9. Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
10. Planned use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
11. Participation in another trial with an investigational drug within 2 months prior to administration or during trial
12. Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
13. Alcohol abuse (> 60 g/day)
14. Drug abuse
15. Blood donation within 1 month prior to administration or during the trial
16. Excessive physical activities within 5 days prior to administration or during the trial
17. Any laboratory value outside the reference range, unless considered to lack clinical reference
18. Female gender
19. Male subjects must agree to minimize the risk of female partners becoming pregnant from the 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BIBF 1120 ES

Experimental group

Treatment:

Drug: BIBF 1120 ES