A Study of S-740792 in Healthy Adult Study Participants

NCT ID: NCT06724978

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2025-09-24

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part 3 will be a 3-sequence, 3-period crossover study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Part 3 will be open label.

Study Groups

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Part 1 (Single Ascending Dose)

Participants will receive S-740792 or placebo.

Group Type EXPERIMENTAL

S-740792 Suspension

Intervention Type DRUG

Participants will receive S-740792 as an oral suspension.

Placebo

Intervention Type DRUG

Participants will receive placebo as an oral suspension.

Part 2 (Multiple Ascending Dose)

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

Group Type EXPERIMENTAL

S-740792 Suspension

Intervention Type DRUG

Participants will receive S-740792 as an oral suspension.

Midazolam

Intervention Type DRUG

Participants will receive midazolam as a syrup.

Placebo

Intervention Type DRUG

Participants will receive placebo as an oral suspension.

Part 3 (Bioavailability)

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

Group Type EXPERIMENTAL

S-740792 Suspension

Intervention Type DRUG

Participants will receive S-740792 as an oral suspension.

S-740792 Tablet

Intervention Type DRUG

Participants will receive S-740792 as an oral tablet.

Interventions

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S-740792 Suspension

Participants will receive S-740792 as an oral suspension.

Intervention Type DRUG

Midazolam

Participants will receive midazolam as a syrup.

Intervention Type DRUG

Placebo

Participants will receive placebo as an oral suspension.

Intervention Type DRUG

S-740792 Tablet

Participants will receive S-740792 as an oral tablet.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shionogi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fortrea Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2318VA711

Identifier Type: -

Identifier Source: org_study_id

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