Study of safety, tolerability and pharmacokinetics LYS006 in Japanese healthy male participants
- Conditions
- Healty participants
- Registration Number
- JPRN-jRCT2051200111
- Lead Sponsor
- Yamada Hiroyuki
- Brief Summary
YS006 up to the planned highest dose was safe and well tolerated by Japanese healthy male participants across the entire dose range studied. Following single oral administration of LYS006 at the planned dose levels to Japanese healthy male participants, the plasma concentrations of LYS006 increased with dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Written informed consent must be obtained before any assessment is performed.
- Healthy Japanese male participants 20 to 45 years of age included, and in good health at screening.
- Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 30 kg/m2.
- At screening andbaseline, sitting vital signs should be within the following ranges:
- body temperature between 35.0-37.5 degree
- systolic blood pressure, 90-139 mmHg
- diastolic blood pressure, 50-89 mmHg
- pulse rate, 40-90 bpm
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Use of any prescription drugs, herbal supplements, prescribed medicinal use of cannabis/marijuana, within four weeks prior to initial dosing, and/or over-the-counter medication, dietary supplements (vitamins included) within two weeks prior to initial dosing.
- History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study.
- Hemoglobin levels below 12.0 g/dL at screening.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening :
- PR > 200 msec
- QRS complex > 120 msec
- QTcF > 450 msec
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method