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Completed

NCT Number: NCT06724978

A Study 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

S-740792 Suspension

Drug

Participants will receive S-740792 as an oral suspension.

midazolam

Drug

Participants will receive midazolam as a syrup.

Placebo

Drug

Participants will receive placebo as an oral suspension.

S-740792 Tablet

Drug

Participants will receive S-740792 as an oral tablet.

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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Oct 2, 2025

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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