A Study of S-740792 in Healthy Adult Study Participants

A Phase 1 Single- and Multiple-ascending-dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-740792 in Healthy Adult Study Participants

This is a 3-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose and food effect) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose and drug-drug interaction) will investigate the safety, tolerability, and PK of S-740792, in addition, the effect of multiple doses of S-740792 on the PK of midazolam. Part 3 will investigate the relative bioavailability of S-740792 tablet compared to S-740792 suspension and the food effect on the PK of the S-740792 tablet.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: Midazolam; Drug: S-740792 Suspension; Drug: S-740792 Tablet

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Body mass index within the range 18.5 to 30.0 kilograms/meter squared (inclusive).

Key Exclusion Criteria:

• History or presence of 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.
• Participants who require medication or other treatment (for example, dietary restrictions or physical therapy).
• Participants who have participated in any other clinical study involving an investigational study intervention or any other type of medical research within 28 days or 5 half-lives of that drug (if known), whichever is longer before signing of the informed consent form for this study or who are currently participating in such a study.
• Positive test results of the following at screening or within 6 months prior to administration of study intervention:
• hepatitis B surface antigen
• hepatitis C virus antibody
• serological test for syphilis
• human immunodeficiency virus antigen/antibody
• drug screen
• alcohol screen
• Participants who have used tobacco or nicotine-containing products (including electronic-cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission or a positive cotinine test at screening or on admission.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 (Single Ascending Dose); Participants will receive S-740792 or placebo.	Drug: Placebo; Participants will receive placebo as an oral suspension.; Drug: S-740792 Suspension; Participants will receive S-740792 as an oral suspension.
Experimental: Part 2 (Multiple Ascending Dose); Participants will receive S-740792 or placebo, in addition to midazolam.	Drug: Placebo; Participants will receive placebo as an oral suspension.; Drug: Midazolam; Participants will receive midazolam as a syrup.; Drug: S-740792 Suspension; Participants will receive S-740792 as an oral suspension.
Experimental: Part 3 (Bioavailability); Participants will receive S-740792 as a suspension and as a tablet.	Drug: S-740792 Suspension; Participants will receive S-740792 as an oral suspension.; Drug: S-740792 Tablet; Participants will receive S-740792 as an oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 28
Part 3: Plasma Concentration of S-740792	Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792	Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)

Secondary Outcome Measures

Outcome Measure	Time Frame
Parts 1 and 2: Plasma Concentration of S-740792	Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792	Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
Part 1: Plasma Concentration of S-740792 After a High-fat Meal	Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 1: Tmax of S-740792 After a High-fat Meal	Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
Part 2: Plasma Concentration of Midazolam After Administration of S-740792	Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 2: Tmax of Midazolam After Administration of S-740792	Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 62

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bioavailability; Midazolam; First-in-human; Food Effect; S-740792
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Midazolam
• Other Study ID Numbers: 2318VA711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No