NCT06106334

Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants

A Crossover, Phase 1, Open-label, One-arm Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Male and Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and co-administration with itraconazole

Conditions

• Obesity
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	S309309	Administered as oral capsules
DRUG	Itraconazole	Administered as oral capsules

Timeline

• Start date: 2023-11-15
• Primary completion: 2023-12-08
• Completion: 2024-02-14
• First posted: 2023-10-30
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study