Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects

NCT ID: NCT02182258

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

Brief Summary

The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single iv dosing, including dose proportionality.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo ampoule

Intervention Type: DRUG

BIBF 1120 intravenous

Group Type: ACTIVE_COMPARATOR

BIBF 1120 intravenous solution

Intervention Type: DRUG

BIBF 1120 capsule

Group Type: EXPERIMENTAL

BIBF 1120 soft gelatine capsule

Intervention Type: DRUG

Interventions

BIBF 1120 soft gelatine capsule

Intervention Type: DRUG

BIBF 1120 intravenous solution

Intervention Type: DRUG

Placebo ampoule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy males according to the following criteria:

1. Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests

2. Age ≥18 years and ≤50 years

3. Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2

4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria

1. Any finding from medical examination (including blood pressure, pulse rate, ECG) deviating from normal and of clinical relevance

2. History of or current gastrointestinal, hepatic (including Gilbert's syndrome and history of bilirubin increases) renal, respiratory, cardiovascular, metabolic, immunological or 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 haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri

8. Intake of drugs with a long half-life (>24 h) within 1 month prior to administration or during the trial

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 the trial

11. Smoker (>10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

12. Alcohol abuse (>30 g/day)

13. Drug abuse

14. Blood donation (>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. Male subjects refusing to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after completion of the study. Acceptable methods of contraception for male volunteers include vasectomy no less than 3 months prior to administration, barrier contraception, or a medically accepted contraceptive method. Acceptable methods of contraception for female partners of male volunteers include intra-uterine device, tubal ligation, hormonal contraceptive for at least 2 months and diaphragm with spermicide.

18. Homozygous genotype status for UGT1A1*28, *60 (Gilbert polymorphisms)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1199.75

Identifier Type: -

Identifier Source: org_study_id