Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 in Healthy Male Volunteers.

NCT ID: NCT01276990

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

Brief Summary

To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.

Conditions

HIV Infections; Healthy

Study Design

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

Study Groups

Placebo

Matching placebo in dosing regimen 1-8

Group Type: PLACEBO_COMPARATOR

BI 224436

Intervention Type: DRUG

Oral drinking solution

Placebo

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 1

Dosing regimen 1

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 2

Dosing regimen 2

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 3

Dosing regimen 3

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 4

Dosing regimen 4

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 5

Dosing regimen 5

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 6

Dosing regimen 6

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 7

Dosing regimen 7

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

BI 224436 dosing regimen 8

Dosing regimen 8

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Oral drinking solution

Interventions

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

BI 224436

Oral drinking solution

Intervention Type: DRUG

Placebo

Oral drinking solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests.

2. Age >=18 and <=50 years.

3. Body Mass Index (BMI) >=18.5 and BMI <=32 kg/m2.

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

5. Documented to be sterile; or, if can father a child, agree to abstain from sexual intercourse during and at least seven days following last study drug administration, or are willing to use condoms during the same period each time (Subject's female sexual partner(s) of child-bearing potential should be willing to use either ethinyl estradiol containing oral contraceptives or a reliable barrier method of contraception).

Exclusion Criteria

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

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 that in the opinion of the investigator may affect the absorption.

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. History or evidence of Human Immunodeficiency Virus or other chronic or relevant acute infections, including Hepatitis C Virus and Hepatitis B Virus infection.

8. History of relevant allergy / hypersensitivity (including allergy to investigational medicinal product or its solvent).

9. History of any familial skeletal muscle disorder, or history of Creatine Kinase (CK) elevation not due to strenuous physical activity or trauma.

10. 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.

11. Use of drugs, including prescription and non-prescription drugs, and St. Johns Wort which might reasonably influence the results of the trial within 14 days prior to study drug administration or during the trial, or consumption of grapefruit, grapefruit juice, orange juice, Seville oranges, green tea, pineapple, pineapple juice, broccoli or red wine within 3 days prior study drug administration or during the trial.

12. Participation in another trial with an investigational drug within one month prior to administration or during the trial.

13. Current smoker (>10 cigarettes or >3 cigars or >3 pipes / day).

14. Inability to refrain from smoking during the trial.

15. Alcohol abuse (more than 30 g day).

16. Drug abuse.

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

18. Physical activity in excess of usual activity of daily living (e.g., fitness physical exercise, physical labor) within 7 days prior to study drug administration until end of study visit.

19. Any laboratory value outside the reference range that in the opinion of the investigator is of clinical relevance.

20. A marked baseline prolongation of QT or corrected QT (QTc) intervals (e.g., repeated demonstration of a QTc interval >450 ms); or, other ECG abnormality of clinical significance.

21. A history of additional risk factors for Torsades de points (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

22. CK at screening =2x Upper Limit of Normal (ULN) (If CK is =2xULN and <5xULN one retest will be allowed to verify the result).

23. CK at baseline (Day -1) >ULN (If CK is >ULN and <1.5xULN one retest will be allowed to verify the result).

24. Thyroid - stimulating hormone outside normal reference range, or history of hypo-or hyperthyroidism.

• 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

Other Identifiers

1277.2

Identifier Type: -

Identifier Source: org_study_id