NCT05247970

A Study to Assess S-309309 in Healthy and Obese Participants

A Phase 1 Randomized, Double-blind, Single and Multiple-dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of S-309309 in Healthy and Obese Adult Study Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

Detailed description

This study will consist of 2 Parts. Part 1 will include healthy participants who will be assigned to a dose group. Participants will then be randomized to receive a single oral administration of S-309309 or placebo in a fasted state. Administration will be initiated in the lowest dose group, and administration in the next dose group will not occur until a review of safety and tolerability has been completed for the preceding group. Part 2 will include 2 groups. Healthy participants and obese but otherwise healthy participants will receive multiple oral administrations of S-309309 or placebo in a fed state.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	S-309309	Capsule administered orally
DRUG	Midazolam	Syrup administered orally
DRUG	Placebo	Matching capsule to S-309309 administered orally

Timeline

• Start date: 2022-01-04
• Primary completion: 2022-10-20
• Completion: 2022-11-01
• First posted: 2022-02-21
• Last updated: 2023-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study