A Study of S-740792 in Healthy Adult Study Participants

Last updated: September 30, 2025
Sponsor: Shionogi
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

S-740792 Tablet

S-740792

S-740792 Suspension

Clinical Study ID

NCT06724978
2318VA711
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

Exclusion

Key Exclusion Criteria:

  • History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrinological, hematological, or neurological disorders capableof significantly altering the absorption, metabolism, or elimination of drugs;constituting a risk when taking the study intervention; or interfering with theinterpretation of data.

  • Participants who require medication or other treatment (for example, dietaryrestrictions or physical therapy).

  • Participants who have participated in any other clinical study involving aninvestigational study intervention or any other type of medical research within 28days or 5 half-lives of that drug (if known), whichever is longer before signing ofthe informed consent form for this study or who are currently participating in sucha study.

  • Positive test results of the following at screening or within 6 months prior toadministration 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 (includingelectronic-cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, andnicotine gum) within 6 months prior to admission or a positive cotinine test atscreening or on admission.

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

Study Design

Total Participants: 99
Treatment Group(s): 5
Primary Treatment: S-740792 Tablet
Phase: 1
Study Start date:
November 21, 2024
Estimated Completion Date:
September 24, 2025

Connect with a study center

  • Fortrea Clinical Research Unit, Inc.

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Fortrea Clinical Research Unit, Inc.

    Daytona Beach 4152872, Florida 4155751 32117
    United States

    Site Not Available

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