A Study to Assess S-309309 in Healthy and Obese Participants
- Registration Number
- NCT05247970
- Lead Sponsor
- Shionogi
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2: S-309309 and Midazolam Midazolam Participants will receive S-309309 and Midazolam at specific timepoints fed state. Part 2: S-309309 and Midazolam S-309309 Participants will receive S-309309 and Midazolam at specific timepoints fed state. Part 1: S-309309 S-309309 Participants will receive S-309309 at specific timepoints in a fasted state. Part 1 and 2: Placebo Placebo Participants will receive a matching placebo to S-309309 at specific timepoints in either a fed or fasted state.
- Primary Outcome Measures
Name Time Method Part 1 and 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) Up to Day 28
- Secondary Outcome Measures
Name Time Method Part 1: Apparent Total Clearance (CL/F) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Renal Clearance (CLR) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Change From Baseline of Electrocardiogram (ECG) Parameters: QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), Pulse Rate (PR) Interval, and Combination of the Q, R, and S Waves (QRS) Duration Baseline, Day 2, 5, 7 and 16 Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration Baseline, Day 2, 5, 7 and 16 Part 2: Cmax of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 2: AUC of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 2: λz of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 1: Terminal Elimination Rate Constant (λz) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Maximum Plasma Concentration (Cmax) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Mean Residence Time (MRT) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS Baseline up to Day 16 Part 2: CL/F of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 1: Apparent Volume of Distribution (Vz/F) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309 0 (predose) up to 144 hours postdose on Day 1 to Day 21 Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR Baseline, Day 2, 3, 4, 5, 6, 7 and 16 Part 2: t1/2,z of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 2: Vz/F of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR) Baseline, Day 2, 3, 4, 5, 6, 7 and 16 Part 2: Number of Participants with TEAEs After Coadministration with Midazolam Up to Day 28 Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave Baseline up to Day 16 Part 2: Tmax of S-309309 and Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16 Part 2: MRT of Midazolam 0 (predose) up to 24 hours postdose on Day -2 to Day 16
Trial Locations
- Locations (1)
ICON Early Phase Services, LLC
🇺🇸San Antonio, Texas, United States