A Study of S-740792 in Healthy Adult Study Participants

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: S-740792; Drug: Placebo; Drug: Midazolam

• Registration Number: NCT06724978
• Lead Sponsor: Shionogi

Brief Summary

This is a 2-part study of S-740792 in healthy adult participants. Part 1 (single-ascending-dose) will investigate the safety, tolerability, and pharmacokinetics (PK) of S-740792. Part 2 (multiple-ascending-dose) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-21
• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-09-02
• Study Completion: 2025-09-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1 (Single Ascending Dose)	S-740792	Participants will receive S-740792 or placebo.
Part 1 (Single Ascending Dose)	Placebo	Participants will receive S-740792 or placebo.
Part 2 (Multiple Ascending Dose)	S-740792	Participants will receive S-740792 or placebo, in addition to midazolam.
Part 2 (Multiple Ascending Dose)	Midazolam	Participants will receive S-740792 or placebo, in addition to midazolam.
Part 2 (Multiple Ascending Dose)	Placebo	Participants will receive S-740792 or placebo, in addition to midazolam.

Primary Outcome Measures

Name	Time	Method
Parts 1 and 2: Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 28

Secondary Outcome Measures

Name	Time	Method
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)
Part 2: Tmax of Midazolam After Administration of S-740792	Day -1 (pre-administration of midazolam) and Day 14 (up to 24 hours post-administration)

Trial Locations

Locations (1)

Fortrea Clinical Research Unit, Inc.; 🇺🇸 Daytona Beach, Florida, United States