A Study to Assess S-309309 in Healthy and Obese Participants

Shionogi74 enrolled

Overview

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

S-309309DRUG

Capsule administered orally

MidazolamDRUG

Syrup administered orally

PlaceboDRUG

Matching capsule to S-309309 administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Locations (1)

ICON Early Phase Services, LLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to Day 28