geographic atrophy (GA)
Conditions
Interventions
Administrate the study Drug(BI 1584862 or Placebo) Single dose.
Sponsors
Wu Haoyu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male subjects, age of 18 to 45 years (inclusive), body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive)
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| AUC0-tz and Cmax of BI 1584862 in plasma | — |
Contacts
Public ContactTomohiro Yamagami
Boehringer Ingelheim
Outcome results
None listed