Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers

NCT ID: NCT02183545

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief Summary

The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.

Conditions

Healthy

Study Design

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

Study Groups

BI 1060469

single rising doses given as tablet

Group Type: EXPERIMENTAL

BI 1060469

Intervention Type: DRUG

single rising doses given as tablet

Placebo

given as tablet (matching placebo of BI 1060469)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

given as tablet (matching placebo of BI 1060469)

Interventions

BI 1060469

single rising doses given as tablet

Intervention Type: DRUG

Placebo

given as tablet (matching placebo of BI 1060469)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Chinese ethnicity, Japanese ethnicity according to the following criteria:

Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan

3. Age within the range of 18 to 45 years

4. Body mass index within the range of 18.5 and 25 kg/m2

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

Exclusion Criteria

1. Any finding in the medical examination (including blood pressure, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.

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

3. Serum creatinine laboratory value outside the normal range

4. Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Formula < 60 ml/ min

5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)

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

7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

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

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

10. Relevant chronic or acute infections

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

12. Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration

13. Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2) inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and drug administration

14. Use of drugs that might reasonably influence the results of the trial (including renal function measurements) or that might prolong the QT/QTc interval within 14 days prior to study drug administration

15. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication

16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)

17. Inability to refrain from smoking on specified trial days

18. Alcohol abuse (consumption of more than 30 g/day)

19. Drug abuse or positive drug screen

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

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

22. Inability to comply with dietary regimen of trial site

23. A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding

24. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)

25. Subject is assessed by the investigator as unsuitable for inclusion, 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: 45 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

1333.3.82002 Boehringer Ingelheim Investigational Site

Busan, , South Korea

1333.3.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1333.3

Identifier Type: -

Identifier Source: org_study_id