Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Taisho Pharmaceutical R&D Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy adult male and female participants between 18 and 55 years of age, inclusive
Body weight ≥ 45 kg
Body Mass Index (BMI) 18 - 30 kg/m\^2, inclusive
You may not be if
Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
History or presence of psychiatric or neurologic disease or condition
History of seizures
Abnormal EEG observed at screening
Abnormal blood pressure
Breast cancer within the past 10 years, or any other malignancies within the past 5 years
Clinically significant abnormal results in electrocardiogram, blood and urine test
History or presence of liver disease
Participants using medication or supplements within 14 days prior to dosing
Use of N-methyl-D-aspartate (NMDA) receptor modulators (example: dextromethorphan, ketamine, amantadine, memantine) within 90 days of screening
Loss of blood or blood products in excess of 450 mL within 60 days prior to screening
Used any investigational drug within 60 days prior to screening
Recent history of alcohol or drug abuse
Any participant who currently uses or has used tobacco products or nicotine-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) for one month or more prior to screening
Significant abnormalities in lumbar spine
History of clinically significant back pain, back pathology, and/or back injury
History of migraines, and/or frequent, severe headaches
History or presence of significant active bleeding or coagulation disorder or use of non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
Allergy to lidocaine (Xylocaine®) or related drugs
History of adverse reaction to lumbar puncture or epidural procedure
Clareo Health | First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants
