Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers

NCT ID: NCT02259842

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

Brief Summary

Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 34021 FU2 solution

single rising doses, dose groups 3 and 5 double-dosing (fed and fasted)

Group Type: EXPERIMENTAL

BI 34021 FU2 solution

Intervention Type: DRUG

High fat, high calorie breakfast

Intervention Type: OTHER

only for dose groups 3 and 5

BI 34021 FU2 tablet

dose group 4 only

Group Type: EXPERIMENTAL

BI 34021 FU2 tablet

Intervention Type: DRUG

dose group 4 only

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BI 34021 FU2 solution

Intervention Type: DRUG

BI 34021 FU2 tablet

dose group 4 only

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

High fat, high calorie breakfast

only for dose groups 3 and 5

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

2. Age ≥21 and Age ≤50 years

3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

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

4. Surgery of the gastrointestinal tract (except appendectomy)

5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

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

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

9. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial

11. Participation in another trial with an investigational drug within two months prior to administration or during the trial

12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

13. Inability to refrain from smoking on trial days

14. Alcohol abuse (more than 60 g/day)

15. Drug abuse

16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

17. Excessive physical activities (within one week prior to administration or during the trial)

18. Any laboratory value outside the reference range that is of clinical relevance

19. Inability to comply with dietary regimen of trial site

20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)

21. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

22. Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device (IUD) during the whole study period from the time of the first intake of study drug until three months after the last intake

• Minimum Eligible Age: 21 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

1258.1

Identifier Type: -

Identifier Source: org_study_id