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CompletedNCT06724978Updated Oct 2, 2025

A Study of S-740792 in Healthy Adult Study Participants

A Phase 1 interventional study of S-740792 Suspension and Midazolam in Healthy Participants, sponsored by Shionogi. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Shionogi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Participants

Keywords

  • First-in-human
  • S-740792
  • Midazolam
  • Bioavailability
  • Food Effect
03

In context

Lead sponsor

Shionogi is the lead sponsor of 104 studies on the registry; 10 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    Part 1 (Single Ascending Dose)

    Participants will receive S-740792 or placebo.

    Drug: S-740792 Suspension · Drug: Placebo

  • Experimental
    Part 2 (Multiple Ascending Dose)

    Participants will receive S-740792 or placebo, in addition to midazolam.

    Drug: S-740792 Suspension · Drug: Midazolam · Drug: Placebo

  • Experimental
    Part 3 (Bioavailability)

    Participants will receive S-740792 as a suspension and as a tablet.

    Drug: S-740792 Suspension · Drug: S-740792 Tablet

Interventions

  • DrugS-740792 Suspension

    Participants will receive S-740792 as an oral suspension.

  • DrugMidazolam

    Participants will receive midazolam as a syrup.

  • DrugPlacebo

    Participants will receive placebo as an oral suspension.

  • DrugS-740792 Tablet

    Participants will receive S-740792 as an oral tablet.

06

What researchers measure

Primary outcomes

  1. Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 28

  2. Part 3: Plasma Concentration of S-740792

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)

  3. Part 3: Time to Maximum Plasma Concentration (Tmax) of S-740792

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)

Secondary outcomes

  1. Parts 1 and 2: Plasma Concentration of S-740792

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28

  2. Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of S-740792

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28

  3. Part 1: Plasma Concentration of S-740792 After a High-fat Meal

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14

  4. Part 1: Tmax of S-740792 After a High-fat Meal

    Time frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14

  5. Part 2: Plasma Concentration of Midazolam After Administration of S-740792

    Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)

  6. Part 2: Tmax of Midazolam After Administration of S-740792

    Time frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)

  7. Part 3: Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 62

07

Study locations

1 site
  • Fortrea Clinical Research Unit, Inc.
    Daytona Beach, Florida 32117, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06724978
Lead sponsor
Shionogi
Responsible party
Sponsor
First posted
Dec 9, 2024
Start date
Nov 21, 2024
Primary completion
Sep 10, 2025
Completion
Sep 24, 2025
Last update
Oct 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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