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Safety, tolerability and pharmacokinetics of single rising oral doses of BI 894416 versus placebo in healthy male Japanese subjects (single-blind, randomized, placebo-controlled within dose group)

A study in healthy Japanese men to test how different doses of BI 894416 are tolerated

Nippon Boehringer Ingelheim Co., Ltd.

2-1-1 Osaki Shinkupakutawa(17-kai), Shinagawa-ku, Tokyo-to 141-6017

https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

Nippon Boehringer Ingelheim Co., Ltd.

2-1-1 Osaki Shinkupakutawa(17-kai), Shinagawa-ku, Tokyo-to 141-6017

https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

suspended

Oct. 05, 2020

Interventional

This single rising dose trial is designed as single-blind, randomised, and placebo-controlled within dose groups. It is planned to include a total of 24 healthy male subjects in the trial. The subjects will be assigned to 3 groups consisting of 8 subjects per group; the groups will be dosed sequentially. Within each dose group, 6 subjects will receive BI 894416 and 2 will receive placebo. Only one dose is tested within each dose group.

other

1

1.Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2.Japanese ethnicity, according to the following criteria:
-born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
3.Age of 20 to 45 years (inclusive) at screening
4.BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening
5.Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
6.Male subjects with WOCBP partner who are willing to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 90 days thereafter.

1.Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2.Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3.Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4.Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5.Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6.Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
7.Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders
8.History of relevant orthostatic hypotension, fainting spells, or blackouts
9.Chronic or relevant acute infections
10.History of relevant allergy or hypersensitivity, including allergy to the trial medication or its excipients
11.Use of drugs within 30 d of planned administration of trial medication that might reasonably influence the results of the trial, including drugs that cause QT/QTc interval prolongation
12.Intake of an investigational drug in another clinical trial within 60 d of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
13.Smoker, unless the subject quit smoking for at least 12 months prior to first planned administration of trial medication
14.Inability to refrain from smoking during trial
15.Alcohol abuse, i.e. consumption of more than 30 g per day
16.Drug abuse or positive drug screening
17.Blood donation of more than 400 mL within 12 weeks, or 200 mL within 30 d, or plasma donation within 2 weeks prior to administration, or intended blood donation during the trial
18.Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
19.Inability to comply with the dietary regimen of the trial site
20.A marked baseline prolongation of QT/QTc interval, such as QTc intervals that are repeatedly greater than 450 ms, or any other relevant ECG finding at screening
21.A history of additional risk factors for Torsade de Pointes, such as heart failure, hypokalaemia, or family history of Long QT Syndrome
22.Subject is assessed by the investigator as unsuitable for inclusion, because, for instance, the subject is not considered able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial
23.History of disease that affects the present situation

In addition, the following trial-specific exclusion criteria apply:
24.History of relevant neurological disorder affecting the peripheral or central nervous system, including, but not limited to, stroke, epilepsy, inflammatory or atrophic diseases affecting the nervous system, cluster headache or any cancer of the nervous system*
25.History of immunological disease except allergy not relevant to the trial, such as mild hay fever or dust mite allergy, and except asthma in childhood or adolescence
26.History of cancer, except successfully treated basal cell carcinoma
27.Use of any drug that could reasonably inhibit platelet aggregation or coagulation, e.g. acetylsalicylic acid, within 10 d prior to administration of trial medication, or planned use during the trial or within 7 d after last dose of trial medication

Male

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investigational material(s)
Generic name etc : BI 894416
INN of investigational material : -
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration for Investigational material : 25 mg, 50 mg, 70 mg
Oral with 240 mL of water

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Not applicable
Oral with 240 mL of water

safety
The percentage (%) of subjects with drug related adverse events

pharmacokinetics
Cmax, AUC0 of BI 894416

Sept. 25, 2020