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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers

NCT ID: NCT02057835

Last Updated: 2015-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-05-31

Brief Summary

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BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 691751 low dose 1

BI 691751 low dose 1

Group Type EXPERIMENTAL

Placebo to BI 691751

Intervention Type DRUG

Placebo to BI 691751

BI 691751 low dose 1

Intervention Type DRUG

BI 691751 low dose 1

BI 691751 low dose 2

BI 691751 low dose 2

Group Type EXPERIMENTAL

Placebo to BI 691751

Intervention Type DRUG

Placebo to BI 691751

BI 691751 low dose 2

Intervention Type DRUG

BI 691751 low dose 2

BI 691751 middle dose

BI 691751 middle dose

Group Type EXPERIMENTAL

BI 691751 middle dose

Intervention Type DRUG

BI 691751 middle dose

Placebo to BI 691751

Intervention Type DRUG

Placebo to BI 691751

BI 691751 high dose

BI 691751 high dose

Group Type EXPERIMENTAL

Placebo to BI 691751

Intervention Type DRUG

Placebo to BI 691751

BI 691751 high dose

Intervention Type DRUG

BI 691751 high dose

Interventions

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Placebo to BI 691751

Placebo to BI 691751

Intervention Type DRUG

BI 691751 high dose

BI 691751 high dose

Intervention Type DRUG

BI 691751 middle dose

BI 691751 middle dose

Intervention Type DRUG

Placebo to BI 691751

Placebo to BI 691751

Intervention Type DRUG

BI 691751 low dose 1

BI 691751 low dose 1

Intervention Type DRUG

Placebo to BI 691751

Placebo to BI 691751

Intervention Type DRUG

Placebo to BI 691751

Placebo to BI 691751

Intervention Type DRUG

BI 691751 low dose 2

BI 691751 low dose 2

Intervention Type DRUG

Eligibility Criteria

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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 and holding Japanese passport, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan
3. Age within the range of 20 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 GCP and local legislation.

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm 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. Any evidence of a concomitant disease judged clinically relevant by the investigator
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
5. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
6. Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
7. History of relevant orthostatic hypotension, fainting spells, or blackouts
8. Relevant chronic or acute infections
9. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
10. 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
11. Use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval within 14 days prior to study drug administration
12. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
13. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
14. Inability to refrain from smoking on specified trial days
15. Alcohol abuse (consumption of more than30 g/day)
16. Drug abuse or positive drug screen
17. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
18. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
19. Inability to comply with dietary regimen of trial site
20. 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
21. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
22. 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

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1334.5.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1334.5

Identifier Type: -

Identifier Source: org_study_id