NCT06724978

A Study of S-740792 in Healthy Adult Study Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	S-740792 Suspension	Participants will receive S-740792 as an oral suspension.
DRUG	Midazolam	Participants will receive midazolam as a syrup.
DRUG	Placebo	Participants will receive placebo as an oral suspension.
DRUG	S-740792 Tablet	Participants will receive S-740792 as an oral tablet.

Timeline

• Start date: 2024-11-21
• Primary completion: 2025-09-10
• Completion: 2025-09-24
• First posted: 2024-12-09
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study