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Completed

NCT Number: NCT05247970

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

S-309309

Drug

Capsule administered orally

midazolam

Drug

Syrup administered orally

Placebo

Drug

Matching capsule to S-309309 administered orally

Primary outcomes

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

    Time frame: Up to Day 28

Secondary outcomes

  1. Part 1: Maximum Plasma Concentration (Cmax) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  2. Part 1: Time to Maximum Plasma Concentration (Tmax) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  3. Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  4. Part 1: Terminal Elimination Half-Life (t1/2,z) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  5. Part 1: Terminal Elimination Rate Constant (λz) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  6. Part 1: Mean Residence Time (MRT) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  7. Part 1: Apparent Total Clearance (CL/F) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  8. Part 1: Apparent Volume of Distribution (Vz/F) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  9. Part 1: Renal Clearance (CLR) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  10. Part 1: Fraction of Dose Excreted in Urine (Feu) of S-309309

    Time frame: 0 (predose) up to 144 hours postdose on Day 1 to Day 21

  11. 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

    Time frame: Baseline, Day 2, 5, 7 and 16

  12. Part 1: Change From Baseline of ECG Parameter: Heart Rate (HR)

    Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16

  13. Part 1: Placebo-Corrected Change From Baseline of ECG Parameters: QTcF, PR Interval, and QRS Duration

    Time frame: Baseline, Day 2, 5, 7 and 16

  14. Part 1: Placebo-Corrected Change From Baseline of ECG Parameter: HR

    Time frame: Baseline, Day 2, 3, 4, 5, 6, 7 and 16

  15. Part 1: Number of Participants With Categorical Outlier Values for HR, QTcF, PR, and QRS

    Time frame: Baseline up to Day 16

  16. Part 1: Number of Participants With Treatment-Emergent Changes for T-wave Morphology and Presence of U-wave

    Time frame: Baseline up to Day 16

  17. Part 2: Cmax of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  18. Part 2: Tmax of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  19. Part 2: AUC of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  20. Part 2: t1/2,z of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  21. Part 2: λz of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  22. Part 2: CL/F of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  23. Part 2: Vz/F of S-309309 and Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  24. Part 2: MRT of Midazolam

    Time frame: 0 (predose) up to 24 hours postdose on Day -2 to Day 16

  25. Part 2: Number of Participants with TEAEs After Coadministration with Midazolam

    Time frame: Up to Day 28

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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