臨床研究等提出・公開システム

Safety, tolerability, pharmacokinetics, and pharmacodynamics of
single rising oral doses and multiple oral doses over 10 days of
BI 1815368 in Japanese healthy male subjects (single-blind,
randomised, placebo-controlled, parallel group design)

A study to test how different doses of BI 1815368 are tolerated
and how BI 1815368 is taken up in the body of healthy Japanese
men

Suzuki Yu

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamagami Tomohiro

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Complete

Aug. 19, 2024

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)

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 40 to 90 mmHg, or pulse rate outside the range of 40 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to beof 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. Relevant chronic or acute infections
10. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin
11. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
12. Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)

Male

Healthy male

BI 1815368 group:BI 1815368 single dose, or BI 1815368 single dose and twice a day
Placebo group:BI 1815368 placebo single dose, or BI 1815368 placebo single dose and twice a day

Occurrence of any treatment-emergent adverse event assessed
as drug-related by the investigator

AUC0 to infinity/Cmax/AUCt ss/Cmin ss/Cmax ss

+81-92-283-7701

July. 12, 2024

No

none