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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 113608

Study type: Interventional

Funder types: Industry

Identifiers

NCT01922349

1314.9

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 8 patient groups, including a placebo group

Placebo (Multiple dose)

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Dose 1, Single dose

Experimental group

Description:

Low dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Dose 2, Single dose

Experimental group

Description:

Medium dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Dose 3, Single dose

Experimental group

Description:

High dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Dose 4, Multiple dose

Experimental group

Description:

Low dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Dose 5, Multiple dose

Experimental group

Description:

Medium dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Dose 6, Multiple dose

Experimental group

Description:

High dose

Treatment:

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Drug: BI 113608

Placebo (Single dose)

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo