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

JRCT ID: jRCT2071240039

Registered date:23/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy male
• Date of first enrollment: 16/08/2024
• Target sample size: 26
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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

• Secondary Outcome: AUC0 to infinity/Cmax/AUCt ss/Cmin ss/Cmax ss

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male
• Include criteria: Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)

Exclude criteria

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)

Related Information

• Primary Sponsor: Suzuki Yu