A Study of S-740792 in Healthy Adult Study Participants

NCT06724978 | Completed Phase 1 FDA Drug

• 1 other identifier: 2318VA711
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

First-in-human; S-740792; Midazolam; Bioavailability; Food Effect

Outcome Measures

Primary Outcomes (3)

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

  Day 1 through Day 28

• Part 3: Plasma Concentration of S-740792

  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

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

Secondary Outcomes (7)

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

  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

  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

  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

  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

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

Study Arms (3)

Part 1 (Single Ascending Dose)

EXPERIMENTAL

Participants will receive S-740792 or placebo.

Drug: S-740792 Suspension; Drug: Placebo

Part 2 (Multiple Ascending Dose)

EXPERIMENTAL

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

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

Part 3 (Bioavailability)

EXPERIMENTAL

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

Drug: S-740792 Suspension; Drug: S-740792 Tablet

Interventions

S-740792 Suspension DRUG

Participants will receive S-740792 as an oral suspension.

Part 1 (Single Ascending Dose); Part 2 (Multiple Ascending Dose); Part 3 (Bioavailability)

Midazolam DRUG

Participants will receive midazolam as a syrup.

Part 2 (Multiple Ascending Dose)

Placebo DRUG

Participants will receive placebo as an oral suspension.

Part 1 (Single Ascending Dose); Part 2 (Multiple Ascending Dose)

S-740792 Tablet DRUG

Participants will receive S-740792 as an oral tablet.

Part 3 (Bioavailability)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Fortrea Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 3 will be open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 3 will be a 3-sequence, 3-period crossover study.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 9, 2024
• Study Start: November 21, 2024
• Primary Completion: September 10, 2025
• Study Completion: September 24, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)