Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers

NCT ID: NCT01922349

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-05-31

Brief Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.

Conditions

Healthy

Study Design

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

Study Groups

Placebo (Multiple dose)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (Multiple dosing)

Dose 1, Single dose

Low dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

Low dose (Single dosing)

Dose 2, Single dose

Medium dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

Medium dose (Single dosing)

Dose 3, Single dose

High dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

High dose (Single dosing)

Dose 4, Multiple dose

Low dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

Low dose (Multiple dosing)

Dose 5, Multiple dose

Medium dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

Medium dose (Multiple dosing)

Dose 6, Multiple dose

High dose

Group Type: EXPERIMENTAL

BI 113608

Intervention Type: DRUG

High dose (Multiple dosing)

Placebo (Single dose)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (Single dosing)

Interventions

BI 113608

Medium dose (Multiple dosing)

Intervention Type: DRUG

Placebo

Placebo (Multiple dosing)

Intervention Type: DRUG

BI 113608

Low dose (Multiple dosing)

Intervention Type: DRUG

Placebo

Placebo (Single dosing)

Intervention Type: DRUG

BI 113608

High dose (Single dosing)

Intervention Type: DRUG

BI 113608

Medium dose (Single dosing)

Intervention Type: DRUG

BI 113608

Low dose (Single dosing)

Intervention Type: DRUG

BI 113608

High dose (Multiple dosing)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan Chinese; ethnic 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
• Caucasian
• Age older than 20 and younger than 45 years
• Normal lung function testing
• Normal peripheral oxygen saturation as determined by non-invasive pulse oxymetry
• Body Mass Index more than 18.5 and Body Mass Index less than 25 kg/m2 for Japanese and Chinese
• Body Mass Index more than 18.5 and Body Mass Index less than 29.9 kg/m2 for Caucasians
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

Exclusion Criteria

• Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• 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
• 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
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 20 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
• A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

• Minimum Eligible Age: 20 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

1314.9.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1314.9

Identifier Type: -

Identifier Source: org_study_id