Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shionogi
This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group.
Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG at the Screening Visit and upon admission to the clinical research unit (CRU).
Body weight ≥50 kilograms (kg), and body mass index (BMI) within the range ≥18.5 to \<30.0 kilogram/meter square (kg/m\^2) for all groups except Group G-2. For Group G-2, BMI ≥ 30 to \< 40 kg/m2 at the Screening Visit.
You may not be if
History or presence of/significant history of or current 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.
Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Breast cancer within the past 10 years.
Unable to swallow capsules.
Chronic history of or current liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Clareo Health | A Study to Assess S-309309 in Healthy and Obese Participants
