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

NCT ID: NCT02183662

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30

Brief Summary

To investigate safety and pharmacokinetics of BI 224436 ZW

Conditions

Healthy

Study Design

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

Study Groups

BI 224436

Group Type: EXPERIMENTAL

BI 224436

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo to BI 224436

Intervention Type: DRUG

Interventions

BI 224436

Intervention Type: DRUG

Placebo to BI 224436

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males

2. Age ≥21 and Age ≤50 years

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

4. Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation.

Exclusion Criteria

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (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. HIV infection and other 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 within 10 days prior to administration or during the trial

11. Participation in another trial with an investigational drug within one month 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 treatment period)

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

19. A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)

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

21. Bradycardia (PR <60 beats/min)

• 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

1277.1

Identifier Type: -

Identifier Source: org_study_id