Relative Bioavailability of 2 Oral Formulations of Nintedanib

NCT ID: NCT02572752

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

Brief Summary

To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment T (Test)

Nintedanib, 1 capsule, oral with 240 mL of water

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

1 soft gelatine capsule, single dose, oral

Treatment R - 1 (Reference)

Nintedanib, 2 capsules, oral with 240 mL of water

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Nintedanib, 2 soft gelatine capsules, single dose, oral

Treatment R - 2 (Reference)

Nintedanib, 2 capsules, oral with 240 mL of water

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

Interventions

Nintedanib

1 soft gelatine capsule, single dose, oral

Intervention Type: DRUG

Nintedanib

Nintedanib, 2 soft gelatine capsules, single dose, oral

Intervention Type: DRUG

Nintedanib

Intervention Type: DRUG

Other Intervention Names

Nintedanib, 2 soft gelatine capsules, single dose, oral

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.

2. Age of 18 to 50 years (incl.)

3. Body weight of at least 70 kg

4. BMI of 21 to 31 kg/m2 (incl.)

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

6. Male subjects, who are willing to use a medically acceptable method of contraception during the first 3 months after administration of nintedanib. Acceptable methods of contraception for use by male volunteers include sexual abstinence, a vasectomy performed at least 1 year prior to dosing and barrier contraception (condom). Subjects, who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception will be used by his female partner such as IUD (intrauterine device), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first nintedanib administration, or barrier method (e.g. diaphragm with spermicide).

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

8. History of relevant orthostatic hypotension, fainting spells, or blackouts

9. Chronic or relevant acute infections

10. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

11. Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication

12. Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial

13. Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication

14. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

15. Inability to refrain from smoking on specified trial days

16. Alcohol abuse (consumption of more than 30 g per day for males)

17. Drug abuse or positive drug screening

18. Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial

19. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

20. Inability to comply with dietary regimen of trial site

21. Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

• 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

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2015-001348-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.237

Identifier Type: -

Identifier Source: org_study_id