A Study of S-740792 in Healthy Adult Study Participants

September 30, 2025 updated by: Shionogi

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events
Time Frame: Day 1 through Day 28
Day 1 through Day 28
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)
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
Time Frame: Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)
Day 1 (pre-administration, up to 144 hours post-administration) of periods 1-3 (10 days/period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: Day 1 (pre-administration, up to 144 hours post-administration), Days 10, 14, 24, and 28
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
Time Frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
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
Time Frame: Day 1 (pre-administration, up to 144 hours post-administration), Day 10, and Day 14
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
Time Frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
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
Time Frame: Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)
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
Time Frame: Day 1 through Day 62
Day 1 through Day 62

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shionogi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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