A study to test how different doses of BI 1015550 are taken up in the body of healthy Japanese men

JRCT ID: jRCT2071230092

Registered date:21/11/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 21/11/2023
• Target sample size: 12
• Countries of recruitment: none,Japan
• Study type: Interventional
• Intervention(s): one dose of BI 1015550(9mg or 18mg)

Outcome(s)

Primary Outcome

-area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
-Cmax (maximum measured concentration of the analyte in plasma)

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

-Any finding in the medical examination (including BP, PR, RR or ECG) deviating from
normal and assessed as clinically relevant by the investigator
-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 PR outside the range of
40 to 99 bpm
-Any laboratory value outside the reference range that the investigator considers to be of
clinical relevance
-Any evidence of a concomitant disease assessed as clinically relevant by the investigator
-Any documented active or suspected malignancy or history of malignancy within 5 years
prior to screening, except appropriately treated basal cell carcinoma or in situ squamous
cell carcinoma of the skin or in situ carcinoma of uterine cervix
-Inability to comply with the dietary regimen of the trial site
-A marked prolongation of QT/QTc interval (such as QTc intervals that are repeatedly
greater than 450 ms in male) or any other relevant ECG finding at screening.
-A history of additional risk factors for Torsade de Pointes (such as heart failure,
hypokalaemia, or family history of Long QT Syndrome)
-Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted
attempt, or preparatory acts or behavior)
-History of vasculitis

Related Information

• Primary Sponsor: Mochizuki Toko