Alzheimers disease
Conditions
Interventions
Oral administration of S-898270 or placebo
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy Japanese adults or healthy White adults: 18 to 55 years of age (inclusive), at the time of signing the informed consent. Healthy Japanese elderly: 65 years of age or older, at the time of signing the informed consent. - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram. - Male or female.
Exclusion criteria
Exclusion criteria: - Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. - Systolic blood pressure is outside the range of 90 to 140 mmHg (90 to 150 mmHg for healthy Japanese elderly), diastolic blood pressure is outside the range of 50 to 90 mmHg, or pulse rate is outside the range of 50 to 100 bpm, and considered ineligible for the study by the investigator. - Presence or history of unexplained syncope, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolongation, or conduction abnormalities. - History of risk factors of torsade de pointes (eg, heart failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome). - Presence or history of electrolyte abnormalities. - History of gastrointestinal surgery such as gastrectomy and enterectomy that may lead to clinically significant gastrointestinal dysfunction. - Presence or chronic history of liver disease or known hepatic or biliary abnormalities. - Presence or history of significant psychiatric diseases (eg, depression, schizophrenia, bipolar disorder, anxiety disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory tests (hematology, blood chemistry, urinalysis), vital signs (systolic/diastolic blood pressure, pulse rate, respiratory rate, body temperature), 12-lead ECG, and Colombia-Suicide Severity Rating Scale, and electroencephalography | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed