A study in healthy men to test how BI 474121 is tolerated

JRCT ID: jRCT2071210040

Registered date:07/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer disease and Cognitive impairment associated with schizophrenia
• Date of first enrollment: 28/07/2021
• Target sample size: 32
• Study type: Interventional

Intervention(s)

Investigational medicine : BI 474121(dose: 2.5 mg/5 mg/10 mg/20 mg)oral medication or
Other: Placebo oral medication

Outcome(s)

• Primary Outcome: Percentage of subjects with drug-related adverse events
• Secondary Outcome: AUC0and Cmax of BI 474121

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

Healthy male subjects according to the assessment of the investigator, as based on a
complete medical history including a physical examination, vital signs (blood
pressure[BP], PR) including body temperature, 12-lead ECG, and clinical laboratory tests
at screening visit

• Exclude criteria: Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit

Related Information

• Primary Sponsor: Takada Kumiko
• Secondary ID(s): NCT04964453