A study in healthy men to test how well different doses of BI 1584862 are tolerated

JRCT ID: jRCT2071230088

Registered date:10/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: geographic atrophy (GA)
• Date of first enrollment: 22/12/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Administrate the study Drug(BI 1584862 or Placebo) 20mg,50mg,100mg or 200mg. Single dose.

Outcome(s)

• Primary Outcome: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator. This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
• Secondary Outcome: AUC0-tz and Cmax of BI 1584862 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 24.9 kg/m2 (inclusive)

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.
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 bpm at screening visit.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit.
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Related Information

• Primary Sponsor: Wu Haoyu
• Secondary ID(s): NCT06148948